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OP RSH PRO00046058 NRG-GI012 TRAN PLAN B DURVALUMAB +TREMELIMUMAB	

Types:      Research Oncology Treatment
Synonyms:  PRO00046058 NRG-GI012

Cycle 1 (Month 1)	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   
NRG-GI012_Tran[AR1]
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for  Treatment: Refer to 6.
Protocol Access Hyperlink:  
NRG-GI012_Tran[AR1]
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Radiotherapy (SBRT)
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Child Pugh Score. After EOT every 3 months for 2 years , every 6 months for 3 years, then annually
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	mALBI Score. After EOT every 3 months for 2 years ,  every 6 months for 3 years , then annually
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	AE Assessment per CTCAE v5.0a. Up to 18 months from randomization
			Nursing Orders
  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	Please ensure thyroid function tests (TSH, Free T4, and T3) are assessed at least every 4 weeks.
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T3	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Research Labs
  	ONC NURSING COMMUNICATION 73	Interval: --	Occurrences: --	Comments:	WHOLE BLOOD for DNA. As clinically indicated. Pre-treatment: 
If sites miss collection of WB01, then sites can collect at any other visit instead but must comment on Biospecimen Transmittal form and use code (WB02)
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	SERUM. 
During Treatment:
C1D1 of immunotherapy (SB02)
C3D1 of immunotherapy (SB03)
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	PLASMA. 
During Treatment:
C1D1 of immunotherapy (PB02)
C3D1 of immunotherapy (PB03)
Post-treatment: (PB04)
Within 14 days of documented radiographic disease progression
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1,000; 
o Platelets LESS than 100,000; 
o AST or ALT GREATER than 3x ULN or Total Bilirubin GREATER than 1.5x ULN; 
o Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline.
			Nursing Orders
  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	Notify physician IF
o TSH GREATER than 10 and free T4 LESS than 0.9 or T3 LESS than 80; 
o TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200.
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Immuno-therapy
  	tremelimumab (IMJUDO) chemo IVPB (RESTRICTED) 300 mg	Dose: 300 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer intravenously over 60 minutes through an IV line containing a sterile, low-protein binding 0.2 or 0.22 micron filter.  
HAZARDOUS - Handle with care / Protect from light. 
Do not freeze and Do not tube/shake. 
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Administer tremelimumab first and observe patient for 60 minutes following completion of tremelimumab infusion, then administer durvalumab as a separate infusion over 60 minutes on the same day.
		  	durvalumab (IMFINZI) 1,500 mg in sodium chloride 0.9% 250 mL (6 mg/mL) IVPB (RESTRICTED)	Dose: 1,500 mg	Route: intravenous	once over 60 Minutes for 1 dose			Offset: 2 Hours	Instructions:	o Administer first dose of durvalumab over 60 min.  If tolerated, all subsequent doses of durvalumab can be administered over 30 minutes. 
o If not administered immediately, may be stored (from the time of preparation to the completion of infusion) for up to 28 days refrigerated at 2°C to 8°C (36°F to 46°F). 
o Administer intravenously via a 0.2 to 0.22 micron low protein binding in-line filter. 
o Do not coadminister with other drugs through the same IV line. 
o Flush line with Normal Saline once completed. Do not shake.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DURVALUMAB 50 MG/ML INTRAVENOUS SOLUTION	Medications	1,500 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	220 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 2 (Month 2)	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   
NRG-GI012_Tran[AR1]
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for  Treatment: Refer to 6.
Protocol Access Hyperlink:  
NRG-GI012_Tran[AR1]
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Radiotherapy (SBRT)
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Child Pugh Score. After EOT every 3 months for 2 years , every 6 months for 3 years, then annually
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	mALBI Score. After EOT every 3 months for 2 years ,  every 6 months for 3 years , then annually
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	AE Assessment per CTCAE v5.0a. Up to 18 months from randomization
			Nursing Orders
  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	Please ensure thyroid function tests (TSH, Free T4, and T3) are assessed at least every 4 weeks.
			Research Labs
  	ONC NURSING COMMUNICATION 73	Interval: --	Occurrences: --	Comments:	WHOLE BLOOD for DNA. As clinically indicated. Pre-treatment: 
If sites miss collection of WB01, then sites can collect at any other visit instead but must comment on Biospecimen Transmittal form and use code (WB02)
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	SERUM. 
During Treatment:
C1D1 of immunotherapy (SB02)
C3D1 of immunotherapy (SB03)
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	PLASMA. 
During Treatment:
C1D1 of immunotherapy (PB02)
C3D1 of immunotherapy (PB03)
Post-treatment: (PB04)
Within 14 days of documented radiographic disease progression
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T3	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1,000; 
o Platelets LESS than 100,000; 
o AST or ALT GREATER than 3x ULN or Total Bilirubin GREATER than 1.5x ULN; 
o Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline.
			Nursing Orders
  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	Notify physician IF
o TSH GREATER than 10 and free T4 LESS than 0.9 or T3 LESS than 80; 
o TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200.
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Immuno-therapy
  	durvalumab (IMFINZI) 1,500 mg in sodium chloride 0.9% 250 mL (6 mg/mL) IVPB (RESTRICTED)	Dose: 1,500 mg	Route: intravenous	once over 60 Minutes for 1 dose			Offset: 2 Hours	Instructions:	o Administer first dose of durvalumab over 60 min.  If tolerated, all subsequent doses of durvalumab can be administered over 30 minutes. 
o If not administered immediately, may be stored (from the time of preparation to the completion of infusion) for up to 28 days refrigerated at 2°C to 8°C (36°F to 46°F). 
o Administer intravenously via a 0.2 to 0.22 micron low protein binding in-line filter. 
o Do not coadminister with other drugs through the same IV line. 
o Flush line with Normal Saline once completed. Do not shake.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DURVALUMAB 50 MG/ML INTRAVENOUS SOLUTION	Medications	1,500 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	220 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 3 (Month 3)	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   
NRG-GI012_Tran[AR1]
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for  Treatment: Refer to 6.
Protocol Access Hyperlink:  
NRG-GI012_Tran[AR1]
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Radiotherapy (SBRT)
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Child Pugh Score. After EOT every 3 months for 2 years , every 6 months for 3 years, then annually
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	mALBI Score. After EOT every 3 months for 2 years ,  every 6 months for 3 years , then annually
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	AE Assessment per CTCAE v5.0a. Up to 18 months from randomization
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	FACT-Hep. AFTER RANDOMIZATION
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	EQ-5D-5L. AFTER RANDOMIZATION
			Nursing Orders
  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	Please ensure thyroid function tests (TSH, Free T4, and T3) are assessed at least every 4 weeks.
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	ALPHA FETOPROTEIN	Interval: --	Occurrences: --			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T3	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --			Research Labs
  	ONC NURSING COMMUNICATION 73	Interval: --	Occurrences: --	Comments:	WHOLE BLOOD for DNA. As clinically indicated. Pre-treatment: 
If sites miss collection of WB01, then sites can collect at any other visit instead but must comment on Biospecimen Transmittal form and use code (WB02)
			Imaging
☑	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Multiphasic liver CT and/or multi-phasic liver MRI. After EOT every 3 months for 2 years, every 6 months for 3 years, then annually.
		☑	CT ABDOMEN WWO CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --		☐	MRI ABDOMEN WO CONTRAST	Interval: --	Occurrences: --		☐	CT ABDOMEN PELVIS W WO CONTRAST	Interval: --	Occurrences: --		☐	CT ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1,000; 
o Platelets LESS than 100,000; 
o AST or ALT GREATER than 3x ULN or Total Bilirubin GREATER than 1.5x ULN; 
o Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline.
			Nursing Orders
  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	Notify physician IF
o TSH GREATER than 10 and free T4 LESS than 0.9 or T3 LESS than 80; 
o TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200.
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Immuno-therapy
  	durvalumab (IMFINZI) 1,500 mg in sodium chloride 0.9% 250 mL (6 mg/mL) IVPB (RESTRICTED)	Dose: 1,500 mg	Route: intravenous	once over 60 Minutes for 1 dose			Offset: 2 Hours	Instructions:	o Administer first dose of durvalumab over 60 min.  If tolerated, all subsequent doses of durvalumab can be administered over 30 minutes. 
o If not administered immediately, may be stored (from the time of preparation to the completion of infusion) for up to 28 days refrigerated at 2°C to 8°C (36°F to 46°F). 
o Administer intravenously via a 0.2 to 0.22 micron low protein binding in-line filter. 
o Do not coadminister with other drugs through the same IV line. 
o Flush line with Normal Saline once completed. Do not shake.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DURVALUMAB 50 MG/ML INTRAVENOUS SOLUTION	Medications	1,500 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	220 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 4 (Month 4)	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   
NRG-GI012_Tran[AR1]
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for  Treatment: Refer to 6.
Protocol Access Hyperlink:  
NRG-GI012_Tran[AR1]
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Radiotherapy (SBRT)
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Child Pugh Score. After EOT every 3 months for 2 years , every 6 months for 3 years, then annually
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	mALBI Score. After EOT every 3 months for 2 years ,  every 6 months for 3 years , then annually
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	AE Assessment per CTCAE v5.0a. Up to 18 months from randomization
			Nursing Orders
  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	Please ensure thyroid function tests (TSH, Free T4, and T3) are assessed at least every 4 weeks.
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T3	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Research Labs
  	ONC NURSING COMMUNICATION 73	Interval: --	Occurrences: --	Comments:	WHOLE BLOOD for DNA. As clinically indicated. Pre-treatment: 
If sites miss collection of WB01, then sites can collect at any other visit instead but must comment on Biospecimen Transmittal form and use code (WB02)
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	Notify physician IF
o TSH GREATER than 10 and free T4 LESS than 0.9 or T3 LESS than 80; 
o TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200.
			Nursing Orders
  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1,000; 
o Platelets LESS than 100,000; 
o AST or ALT GREATER than 3x ULN or Total Bilirubin GREATER than 1.5x ULN; 
o Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline.
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Immuno-therapy
  	durvalumab (IMFINZI) 1,500 mg in sodium chloride 0.9% 250 mL (6 mg/mL) IVPB (RESTRICTED)	Dose: 1,500 mg	Route: intravenous	once over 60 Minutes for 1 dose			Offset: 2 Hours	Instructions:	o Administer first dose of durvalumab over 60 min.  If tolerated, all subsequent doses of durvalumab can be administered over 30 minutes. 
o If not administered immediately, may be stored (from the time of preparation to the completion of infusion) for up to 28 days refrigerated at 2°C to 8°C (36°F to 46°F). 
o Administer intravenously via a 0.2 to 0.22 micron low protein binding in-line filter. 
o Do not coadminister with other drugs through the same IV line. 
o Flush line with Normal Saline once completed. Do not shake.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DURVALUMAB 50 MG/ML INTRAVENOUS SOLUTION	Medications	1,500 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	220 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 5 (Month 5)	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   
NRG-GI012_Tran[AR1]
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for  Treatment: Refer to 6.
Protocol Access Hyperlink:  
NRG-GI012_Tran[AR1]
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Radiotherapy (SBRT)
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Child Pugh Score. After EOT every 3 months for 2 years , every 6 months for 3 years, then annually
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	mALBI Score. After EOT every 3 months for 2 years ,  every 6 months for 3 years , then annually
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	AE Assessment per CTCAE v5.0a. Up to 18 months from randomization
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T3	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	Please ensure thyroid function tests (TSH, Free T4, and T3) are assessed at least every 4 weeks.
			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Research Labs
  	ONC NURSING COMMUNICATION 73	Interval: --	Occurrences: --	Comments:	WHOLE BLOOD for DNA. As clinically indicated. Pre-treatment: 
If sites miss collection of WB01, then sites can collect at any other visit instead but must comment on Biospecimen Transmittal form and use code (WB02)
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	Notify physician IF
o TSH GREATER than 10 and free T4 LESS than 0.9 or T3 LESS than 80; 
o TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200.
			Nursing Orders
  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1,000; 
o Platelets LESS than 100,000; 
o AST or ALT GREATER than 3x ULN or Total Bilirubin GREATER than 1.5x ULN; 
o Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline.
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Immuno-therapy
  	durvalumab (IMFINZI) 1,500 mg in sodium chloride 0.9% 250 mL (6 mg/mL) IVPB (RESTRICTED)	Dose: 1,500 mg	Route: intravenous	once over 60 Minutes for 1 dose			Offset: 2 Hours	Instructions:	o Administer first dose of durvalumab over 60 min.  If tolerated, all subsequent doses of durvalumab can be administered over 30 minutes. 
o If not administered immediately, may be stored (from the time of preparation to the completion of infusion) for up to 28 days refrigerated at 2°C to 8°C (36°F to 46°F). 
o Administer intravenously via a 0.2 to 0.22 micron low protein binding in-line filter. 
o Do not coadminister with other drugs through the same IV line. 
o Flush line with Normal Saline once completed. Do not shake.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DURVALUMAB 50 MG/ML INTRAVENOUS SOLUTION	Medications	1,500 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	220 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 6  (Month 6)	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   
NRG-GI012_Tran[AR1]
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for  Treatment: Refer to 6.
Protocol Access Hyperlink:  
NRG-GI012_Tran[AR1]
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Radiotherapy (SBRT)
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Child Pugh Score. After EOT every 3 months for 2 years , every 6 months for 3 years, then annually
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	mALBI Score. After EOT every 3 months for 2 years ,  every 6 months for 3 years , then annually
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	AE Assessment per CTCAE v5.0a. Up to 18 months from randomization
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	FACT-Hep. AFTER RANDOMIZATION
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	EQ-5D-5L. AFTER RANDOMIZATION
			Nursing Orders
  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	Please ensure thyroid function tests (TSH, Free T4, and T3) are assessed at least every 4 weeks.
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T3	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --			Labs
  	ALPHA FETOPROTEIN	Interval: --	Occurrences: --			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Imaging
☑	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Multiphasic liver CT and/or multi-phasic liver MRI. After EOT every 3 months for 2 years, every 6 months for 3 years, then annually.
		☑	CT ABDOMEN WWO CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --		☐	MRI ABDOMEN WO CONTRAST	Interval: --	Occurrences: --		☐	CT ABDOMEN PELVIS W WO CONTRAST	Interval: --	Occurrences: --		☐	CT ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --			Imaging
  	CT CHEST W WO CONTRAST	Interval: --	Occurrences: --	Comments:	From end of treatment:every 6 months x 2 years; then annually
(IV contrast preferred, but not required)
			Imaging
☐	CT PELVIS W CONTRAST	Interval: --	Occurrences: --		☐	CT PELVIS WO CONTRAST	Interval: --	Occurrences: --		☐	MRI PELVIS W CONTRAST	Interval: --	Occurrences: --		☐	MRI PELVIS WO CONTRAST	Interval: --	Occurrences: --			Research Labs
  	ONC NURSING COMMUNICATION 73	Interval: --	Occurrences: --	Comments:	WHOLE BLOOD for DNA. As clinically indicated. Pre-treatment: 
If sites miss collection of WB01, then sites can collect at any other visit instead but must comment on Biospecimen Transmittal form and use code (WB02)
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	Notify physician IF
o TSH GREATER than 10 and free T4 LESS than 0.9 or T3 LESS than 80; 
o TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200.
			Nursing Orders
  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1,000; 
o Platelets LESS than 100,000; 
o AST or ALT GREATER than 3x ULN or Total Bilirubin GREATER than 1.5x ULN; 
o Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline.
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Immuno-therapy
  	durvalumab (IMFINZI) 1,500 mg in sodium chloride 0.9% 250 mL (6 mg/mL) IVPB (RESTRICTED)	Dose: 1,500 mg	Route: intravenous	once over 60 Minutes for 1 dose			Offset: 2 Hours	Instructions:	o Administer first dose of durvalumab over 60 min.  If tolerated, all subsequent doses of durvalumab can be administered over 30 minutes. 
o If not administered immediately, may be stored (from the time of preparation to the completion of infusion) for up to 28 days refrigerated at 2°C to 8°C (36°F to 46°F). 
o Administer intravenously via a 0.2 to 0.22 micron low protein binding in-line filter. 
o Do not coadminister with other drugs through the same IV line. 
o Flush line with Normal Saline once completed. Do not shake.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DURVALUMAB 50 MG/ML INTRAVENOUS SOLUTION	Medications	1,500 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	220 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 7  (Month 7)	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   
NRG-GI012_Tran[AR1]
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for  Treatment: Refer to 6.
Protocol Access Hyperlink:  
NRG-GI012_Tran[AR1]
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Radiotherapy (SBRT)
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Child Pugh Score. After EOT every 3 months for 2 years , every 6 months for 3 years, then annually
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	mALBI Score. After EOT every 3 months for 2 years ,  every 6 months for 3 years , then annually
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	AE Assessment per CTCAE v5.0a. Up to 18 months from randomization
			Nursing Orders
  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	Please ensure thyroid function tests (TSH, Free T4, and T3) are assessed at least every 4 weeks.
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T3	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Research Labs
  	ONC NURSING COMMUNICATION 73	Interval: --	Occurrences: --	Comments:	WHOLE BLOOD for DNA. As clinically indicated. Pre-treatment: 
If sites miss collection of WB01, then sites can collect at any other visit instead but must comment on Biospecimen Transmittal form and use code (WB02)
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	Notify physician IF
o TSH GREATER than 10 and free T4 LESS than 0.9 or T3 LESS than 80; 
o TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200.
			Nursing Orders
  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1,000; 
o Platelets LESS than 100,000; 
o AST or ALT GREATER than 3x ULN or Total Bilirubin GREATER than 1.5x ULN; 
o Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline.
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Immuno-therapy
  	durvalumab (IMFINZI) 1,500 mg in sodium chloride 0.9% 250 mL (6 mg/mL) IVPB (RESTRICTED)	Dose: 1,500 mg	Route: intravenous	once over 60 Minutes for 1 dose			Offset: 2 Hours	Instructions:	o Administer first dose of durvalumab over 60 min.  If tolerated, all subsequent doses of durvalumab can be administered over 30 minutes. 
o If not administered immediately, may be stored (from the time of preparation to the completion of infusion) for up to 28 days refrigerated at 2°C to 8°C (36°F to 46°F). 
o Administer intravenously via a 0.2 to 0.22 micron low protein binding in-line filter. 
o Do not coadminister with other drugs through the same IV line. 
o Flush line with Normal Saline once completed. Do not shake.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DURVALUMAB 50 MG/ML INTRAVENOUS SOLUTION	Medications	1,500 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	220 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 8  (Month 8)	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   
NRG-GI012_Tran[AR1]
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for  Treatment: Refer to 6.
Protocol Access Hyperlink:  
NRG-GI012_Tran[AR1]
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Radiotherapy (SBRT)
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Child Pugh Score. After EOT every 3 months for 2 years , every 6 months for 3 years, then annually
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	mALBI Score. After EOT every 3 months for 2 years ,  every 6 months for 3 years , then annually
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	AE Assessment per CTCAE v5.0a. Up to 18 months from randomization
			Nursing Orders
  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	Please ensure thyroid function tests (TSH, Free T4, and T3) are assessed at least every 4 weeks.
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T3	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Research Labs
  	ONC NURSING COMMUNICATION 73	Interval: --	Occurrences: --	Comments:	WHOLE BLOOD for DNA. As clinically indicated. Pre-treatment: 
If sites miss collection of WB01, then sites can collect at any other visit instead but must comment on Biospecimen Transmittal form and use code (WB02)
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	Notify physician IF
o TSH GREATER than 10 and free T4 LESS than 0.9 or T3 LESS than 80; 
o TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200.
			Nursing Orders
  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1,000; 
o Platelets LESS than 100,000; 
o AST or ALT GREATER than 3x ULN or Total Bilirubin GREATER than 1.5x ULN; 
o Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline.
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Immuno-therapy
  	durvalumab (IMFINZI) 1,500 mg in sodium chloride 0.9% 250 mL (6 mg/mL) IVPB (RESTRICTED)	Dose: 1,500 mg	Route: intravenous	once over 60 Minutes for 1 dose			Offset: 2 Hours	Instructions:	o Administer first dose of durvalumab over 60 min.  If tolerated, all subsequent doses of durvalumab can be administered over 30 minutes. 
o If not administered immediately, may be stored (from the time of preparation to the completion of infusion) for up to 28 days refrigerated at 2°C to 8°C (36°F to 46°F). 
o Administer intravenously via a 0.2 to 0.22 micron low protein binding in-line filter. 
o Do not coadminister with other drugs through the same IV line. 
o Flush line with Normal Saline once completed. Do not shake.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DURVALUMAB 50 MG/ML INTRAVENOUS SOLUTION	Medications	1,500 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	220 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 9 (Month 9)	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   
NRG-GI012_Tran[AR1]
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for  Treatment: Refer to 6.
Protocol Access Hyperlink:  
NRG-GI012_Tran[AR1]
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Radiotherapy (SBRT)
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Child Pugh Score. After EOT every 3 months for 2 years , every 6 months for 3 years, then annually
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	mALBI Score. After EOT every 3 months for 2 years ,  every 6 months for 3 years , then annually
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	AE Assessment per CTCAE v5.0a. Up to 18 months from randomization
			Nursing Orders
  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	Please ensure thyroid function tests (TSH, Free T4, and T3) are assessed at least every 4 weeks.
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T3	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --			Labs
  	ALPHA FETOPROTEIN	Interval: --	Occurrences: --			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Imaging
☑	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Multiphasic liver CT and/or multi-phasic liver MRI. After EOT every 3 months for 2 years, every 6 months for 3 years, then annually.
		☑	CT ABDOMEN WWO CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --		☐	MRI ABDOMEN WO CONTRAST	Interval: --	Occurrences: --		☐	CT ABDOMEN PELVIS W WO CONTRAST	Interval: --	Occurrences: --		☐	CT ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --			Research Labs
  	ONC NURSING COMMUNICATION 73	Interval: --	Occurrences: --	Comments:	WHOLE BLOOD for DNA. As clinically indicated. Pre-treatment: 
If sites miss collection of WB01, then sites can collect at any other visit instead but must comment on Biospecimen Transmittal form and use code (WB02)
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	Notify physician IF
o TSH GREATER than 10 and free T4 LESS than 0.9 or T3 LESS than 80; 
o TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200.
			Nursing Orders
  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1,000; 
o Platelets LESS than 100,000; 
o AST or ALT GREATER than 3x ULN or Total Bilirubin GREATER than 1.5x ULN; 
o Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline.
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Immuno-therapy
  	durvalumab (IMFINZI) 1,500 mg in sodium chloride 0.9% 250 mL (6 mg/mL) IVPB (RESTRICTED)	Dose: 1,500 mg	Route: intravenous	once over 60 Minutes for 1 dose			Offset: 2 Hours	Instructions:	o Administer first dose of durvalumab over 60 min.  If tolerated, all subsequent doses of durvalumab can be administered over 30 minutes. 
o If not administered immediately, may be stored (from the time of preparation to the completion of infusion) for up to 28 days refrigerated at 2°C to 8°C (36°F to 46°F). 
o Administer intravenously via a 0.2 to 0.22 micron low protein binding in-line filter. 
o Do not coadminister with other drugs through the same IV line. 
o Flush line with Normal Saline once completed. Do not shake.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DURVALUMAB 50 MG/ML INTRAVENOUS SOLUTION	Medications	1,500 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	220 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 10  (Month 10)	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   
NRG-GI012_Tran[AR1]
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for  Treatment: Refer to 6.
Protocol Access Hyperlink:  
NRG-GI012_Tran[AR1]
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Radiotherapy (SBRT)
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Child Pugh Score. After EOT every 3 months for 2 years , every 6 months for 3 years, then annually
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	mALBI Score. After EOT every 3 months for 2 years ,  every 6 months for 3 years , then annually
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	AE Assessment per CTCAE v5.0a. Up to 18 months from randomization
			Nursing Orders
  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	Please ensure thyroid function tests (TSH, Free T4, and T3) are assessed at least every 4 weeks.
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T3	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Research Labs
  	ONC NURSING COMMUNICATION 73	Interval: --	Occurrences: --	Comments:	WHOLE BLOOD for DNA. As clinically indicated. Pre-treatment: 
If sites miss collection of WB01, then sites can collect at any other visit instead but must comment on Biospecimen Transmittal form and use code (WB02)
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	Notify physician IF
o TSH GREATER than 10 and free T4 LESS than 0.9 or T3 LESS than 80; 
o TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200.
			Nursing Orders
  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1,000; 
o Platelets LESS than 100,000; 
o AST or ALT GREATER than 3x ULN or Total Bilirubin GREATER than 1.5x ULN; 
o Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline.
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Immuno-therapy
  	durvalumab (IMFINZI) 1,500 mg in sodium chloride 0.9% 250 mL (6 mg/mL) IVPB (RESTRICTED)	Dose: 1,500 mg	Route: intravenous	once over 60 Minutes for 1 dose			Offset: 2 Hours	Instructions:	o Administer first dose of durvalumab over 60 min.  If tolerated, all subsequent doses of durvalumab can be administered over 30 minutes. 
o If not administered immediately, may be stored (from the time of preparation to the completion of infusion) for up to 28 days refrigerated at 2°C to 8°C (36°F to 46°F). 
o Administer intravenously via a 0.2 to 0.22 micron low protein binding in-line filter. 
o Do not coadminister with other drugs through the same IV line. 
o Flush line with Normal Saline once completed. Do not shake.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DURVALUMAB 50 MG/ML INTRAVENOUS SOLUTION	Medications	1,500 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	220 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 11  (Month 11)	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   
NRG-GI012_Tran[AR1]
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for  Treatment: Refer to 6.
Protocol Access Hyperlink:  
NRG-GI012_Tran[AR1]
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Radiotherapy (SBRT)
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Child Pugh Score. After EOT every 3 months for 2 years , every 6 months for 3 years, then annually
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	mALBI Score. After EOT every 3 months for 2 years ,  every 6 months for 3 years , then annually
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	AE Assessment per CTCAE v5.0a. Up to 18 months from randomization
			Nursing Orders
  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	Please ensure thyroid function tests (TSH, Free T4, and T3) are assessed at least every 4 weeks.
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T3	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Research Labs
  	ONC NURSING COMMUNICATION 73	Interval: --	Occurrences: --	Comments:	WHOLE BLOOD for DNA. As clinically indicated. Pre-treatment: 
If sites miss collection of WB01, then sites can collect at any other visit instead but must comment on Biospecimen Transmittal form and use code (WB02)
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	Notify physician IF
o TSH GREATER than 10 and free T4 LESS than 0.9 or T3 LESS than 80; 
o TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200.
			Nursing Orders
  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1,000; 
o Platelets LESS than 100,000; 
o AST or ALT GREATER than 3x ULN or Total Bilirubin GREATER than 1.5x ULN; 
o Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline.
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Immuno-therapy
  	durvalumab (IMFINZI) 1,500 mg in sodium chloride 0.9% 250 mL (6 mg/mL) IVPB (RESTRICTED)	Dose: 1,500 mg	Route: intravenous	once over 60 Minutes for 1 dose			Offset: 2 Hours	Instructions:	o Administer first dose of durvalumab over 60 min.  If tolerated, all subsequent doses of durvalumab can be administered over 30 minutes. 
o If not administered immediately, may be stored (from the time of preparation to the completion of infusion) for up to 28 days refrigerated at 2°C to 8°C (36°F to 46°F). 
o Administer intravenously via a 0.2 to 0.22 micron low protein binding in-line filter. 
o Do not coadminister with other drugs through the same IV line. 
o Flush line with Normal Saline once completed. Do not shake.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DURVALUMAB 50 MG/ML INTRAVENOUS SOLUTION	Medications	1,500 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	220 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 12  (Month 12)	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   
NRG-GI012_Tran[AR1]
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for  Treatment: Refer to 6.
Protocol Access Hyperlink:  
NRG-GI012_Tran[AR1]
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Radiotherapy (SBRT)
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Child Pugh Score. After EOT every 3 months for 2 years , every 6 months for 3 years, then annually
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	mALBI Score. After EOT every 3 months for 2 years ,  every 6 months for 3 years , then annually
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	AE Assessment per CTCAE v5.0a. Up to 18 months from randomization
			Nursing Orders
  	ONC NURSING COMMUNICATION 47	Interval: --	Occurrences: --	Comments:	FACT-Hep. AFTER RANDOMIZATION
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	EQ-5D-5L. AFTER RANDOMIZATION
			Nursing Orders
  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	Please ensure thyroid function tests (TSH, Free T4, and T3) are assessed at least every 4 weeks.
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T3	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --			Labs
  	ALPHA FETOPROTEIN	Interval: --	Occurrences: --			Imaging
  	CT CHEST W WO CONTRAST	Interval: --	Occurrences: --	Comments:	From end of treatment:every 6 months x 2 years; then annually
(IV contrast preferred, but not required)
			Imaging
☐	CT PELVIS W CONTRAST	Interval: --	Occurrences: --		☐	CT PELVIS WO CONTRAST	Interval: --	Occurrences: --		☐	MRI PELVIS W CONTRAST	Interval: --	Occurrences: --		☐	MRI PELVIS WO CONTRAST	Interval: --	Occurrences: --			Imaging
☑	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Multiphasic liver CT and/or multi-phasic liver MRI. After EOT every 3 months for 2 years, every 6 months for 3 years, then annually.
		☑	CT ABDOMEN WWO CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --		☐	MRI ABDOMEN WO CONTRAST	Interval: --	Occurrences: --		☐	CT ABDOMEN PELVIS W WO CONTRAST	Interval: --	Occurrences: --		☐	CT ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Research Labs
  	ONC NURSING COMMUNICATION 73	Interval: --	Occurrences: --	Comments:	WHOLE BLOOD for DNA. As clinically indicated. Pre-treatment: 
If sites miss collection of WB01, then sites can collect at any other visit instead but must comment on Biospecimen Transmittal form and use code (WB02)
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	Notify physician IF
o TSH GREATER than 10 and free T4 LESS than 0.9 or T3 LESS than 80; 
o TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200.
			Nursing Orders
  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1,000; 
o Platelets LESS than 100,000; 
o AST or ALT GREATER than 3x ULN or Total Bilirubin GREATER than 1.5x ULN; 
o Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline.
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Immuno-therapy
  	durvalumab (IMFINZI) 1,500 mg in sodium chloride 0.9% 250 mL (6 mg/mL) IVPB (RESTRICTED)	Dose: 1,500 mg	Route: intravenous	once over 60 Minutes for 1 dose			Offset: 2 Hours	Instructions:	o Administer first dose of durvalumab over 60 min.  If tolerated, all subsequent doses of durvalumab can be administered over 30 minutes. 
o If not administered immediately, may be stored (from the time of preparation to the completion of infusion) for up to 28 days refrigerated at 2°C to 8°C (36°F to 46°F). 
o Administer intravenously via a 0.2 to 0.22 micron low protein binding in-line filter. 
o Do not coadminister with other drugs through the same IV line. 
o Flush line with Normal Saline once completed. Do not shake.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DURVALUMAB 50 MG/ML INTRAVENOUS SOLUTION	Medications	1,500 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	220 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 13  (Month 13)	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   
NRG-GI012_Tran[AR1]
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for  Treatment: Refer to 6.
Protocol Access Hyperlink:  
NRG-GI012_Tran[AR1]
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Radiotherapy (SBRT)
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Child Pugh Score. After EOT every 3 months for 2 years , every 6 months for 3 years, then annually
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	mALBI Score. After EOT every 3 months for 2 years ,  every 6 months for 3 years , then annually
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	AE Assessment per CTCAE v5.0a. Up to 18 months from randomization
			Nursing Orders
  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	Please ensure thyroid function tests (TSH, Free T4, and T3) are assessed at least every 4 weeks.
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T3	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Research Labs
  	ONC NURSING COMMUNICATION 73	Interval: --	Occurrences: --	Comments:	WHOLE BLOOD for DNA. As clinically indicated. Pre-treatment: 
If sites miss collection of WB01, then sites can collect at any other visit instead but must comment on Biospecimen Transmittal form and use code (WB02)
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	Notify physician IF
o TSH GREATER than 10 and free T4 LESS than 0.9 or T3 LESS than 80; 
o TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200.
			Nursing Orders
  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1,000; 
o Platelets LESS than 100,000; 
o AST or ALT GREATER than 3x ULN or Total Bilirubin GREATER than 1.5x ULN; 
o Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline.
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Immuno-therapy
  	durvalumab (IMFINZI) 1,500 mg in sodium chloride 0.9% 250 mL (6 mg/mL) IVPB (RESTRICTED)	Dose: 1,500 mg	Route: intravenous	once over 60 Minutes for 1 dose			Offset: 2 Hours	Instructions:	o Administer first dose of durvalumab over 60 min.  If tolerated, all subsequent doses of durvalumab can be administered over 30 minutes. 
o If not administered immediately, may be stored (from the time of preparation to the completion of infusion) for up to 28 days refrigerated at 2°C to 8°C (36°F to 46°F). 
o Administer intravenously via a 0.2 to 0.22 micron low protein binding in-line filter. 
o Do not coadminister with other drugs through the same IV line. 
o Flush line with Normal Saline once completed. Do not shake.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DURVALUMAB 50 MG/ML INTRAVENOUS SOLUTION	Medications	1,500 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	220 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 14  (Month 14)	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   
NRG-GI012_Tran[AR1]
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for  Treatment: Refer to 6.
Protocol Access Hyperlink:  
NRG-GI012_Tran[AR1]
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Radiotherapy (SBRT)
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Child Pugh Score. After EOT every 3 months for 2 years , every 6 months for 3 years, then annually
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	mALBI Score. After EOT every 3 months for 2 years ,  every 6 months for 3 years , then annually
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	AE Assessment per CTCAE v5.0a. Up to 18 months from randomization
			Nursing Orders
  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	Please ensure thyroid function tests (TSH, Free T4, and T3) are assessed at least every 4 weeks.
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T3	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	Please ensure thyroid function tests (TSH, Free T4, and T3) are assessed at least every 6 weeks.
			Research Labs
  	ONC NURSING COMMUNICATION 73	Interval: --	Occurrences: --	Comments:	WHOLE BLOOD for DNA. As clinically indicated. Pre-treatment: 
If sites miss collection of WB01, then sites can collect at any other visit instead but must comment on Biospecimen Transmittal form and use code (WB02)
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	Notify physician IF
o TSH GREATER than 10 and free T4 LESS than 0.9 or T3 LESS than 80; 
o TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200.
			Nursing Orders
  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1,000; 
o Platelets LESS than 100,000; 
o AST or ALT GREATER than 3x ULN or Total Bilirubin GREATER than 1.5x ULN; 
o Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline.
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Immuno-therapy
  	durvalumab (IMFINZI) 1,500 mg in sodium chloride 0.9% 250 mL (6 mg/mL) IVPB (RESTRICTED)	Dose: 1,500 mg	Route: intravenous	once over 60 Minutes for 1 dose			Offset: 2 Hours	Instructions:	o Administer first dose of durvalumab over 60 min.  If tolerated, all subsequent doses of durvalumab can be administered over 30 minutes. 
o If not administered immediately, may be stored (from the time of preparation to the completion of infusion) for up to 28 days refrigerated at 2°C to 8°C (36°F to 46°F). 
o Administer intravenously via a 0.2 to 0.22 micron low protein binding in-line filter. 
o Do not coadminister with other drugs through the same IV line. 
o Flush line with Normal Saline once completed. Do not shake.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DURVALUMAB 50 MG/ML INTRAVENOUS SOLUTION	Medications	1,500 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	220 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 15  (Month 15)	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   
NRG-GI012_Tran[AR1]
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for  Treatment: Refer to 6.
Protocol Access Hyperlink:  
NRG-GI012_Tran[AR1]
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Radiotherapy (SBRT)
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Child Pugh Score. After EOT every 3 months for 2 years , every 6 months for 3 years, then annually
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	mALBI Score. After EOT every 3 months for 2 years ,  every 6 months for 3 years , then annually
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	AE Assessment per CTCAE v5.0a. Up to 18 months from randomization
			Nursing Orders
  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	Please ensure thyroid function tests (TSH, Free T4, and T3) are assessed at least every 4 weeks.
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T3	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	ALPHA FETOPROTEIN	Interval: --	Occurrences: --			Imaging
☑	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Multiphasic liver CT and/or multi-phasic liver MRI. After EOT every 3 months for 2 years, every 6 months for 3 years, then annually.
		☑	CT ABDOMEN WWO CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --		☐	MRI ABDOMEN WO CONTRAST	Interval: --	Occurrences: --		☐	CT ABDOMEN PELVIS W WO CONTRAST	Interval: --	Occurrences: --		☐	CT ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --			Research Labs
  	ONC NURSING COMMUNICATION 73	Interval: --	Occurrences: --	Comments:	WHOLE BLOOD for DNA. As clinically indicated. Pre-treatment: 
If sites miss collection of WB01, then sites can collect at any other visit instead but must comment on Biospecimen Transmittal form and use code (WB02)
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	Notify physician IF
o TSH GREATER than 10 and free T4 LESS than 0.9 or T3 LESS than 80; 
o TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200.
			Nursing Orders
  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1,000; 
o Platelets LESS than 100,000; 
o AST or ALT GREATER than 3x ULN or Total Bilirubin GREATER than 1.5x ULN; 
o Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline.
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Immuno-therapy
  	durvalumab (IMFINZI) 1,500 mg in sodium chloride 0.9% 250 mL (6 mg/mL) IVPB (RESTRICTED)	Dose: 1,500 mg	Route: intravenous	once over 60 Minutes for 1 dose			Offset: 2 Hours	Instructions:	o Administer first dose of durvalumab over 60 min.  If tolerated, all subsequent doses of durvalumab can be administered over 30 minutes. 
o If not administered immediately, may be stored (from the time of preparation to the completion of infusion) for up to 28 days refrigerated at 2°C to 8°C (36°F to 46°F). 
o Administer intravenously via a 0.2 to 0.22 micron low protein binding in-line filter. 
o Do not coadminister with other drugs through the same IV line. 
o Flush line with Normal Saline once completed. Do not shake.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DURVALUMAB 50 MG/ML INTRAVENOUS SOLUTION	Medications	1,500 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	220 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 16  (Month 16)	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   
NRG-GI012_Tran[AR1]
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for  Treatment: Refer to 6.
Protocol Access Hyperlink:  
NRG-GI012_Tran[AR1]
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Radiotherapy (SBRT)
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Child Pugh Score. After EOT every 3 months for 2 years , every 6 months for 3 years, then annually
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	mALBI Score. After EOT every 3 months for 2 years ,  every 6 months for 3 years , then annually
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	AE Assessment per CTCAE v5.0a. Up to 18 months from randomization
			Nursing Orders
  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	Please ensure thyroid function tests (TSH, Free T4, and T3) are assessed at least every 4 weeks.
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T3	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Research Labs
  	ONC NURSING COMMUNICATION 73	Interval: --	Occurrences: --	Comments:	WHOLE BLOOD for DNA. As clinically indicated. Pre-treatment: 
If sites miss collection of WB01, then sites can collect at any other visit instead but must comment on Biospecimen Transmittal form and use code (WB02)
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	Notify physician IF
o TSH GREATER than 10 and free T4 LESS than 0.9 or T3 LESS than 80; 
o TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200.
			Nursing Orders
  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1,000; 
o Platelets LESS than 100,000; 
o AST or ALT GREATER than 3x ULN or Total Bilirubin GREATER than 1.5x ULN; 
o Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline.
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Immuno-therapy
  	durvalumab (IMFINZI) 1,500 mg in sodium chloride 0.9% 250 mL (6 mg/mL) IVPB (RESTRICTED)	Dose: 1,500 mg	Route: intravenous	once over 60 Minutes for 1 dose			Offset: 2 Hours	Instructions:	o Administer first dose of durvalumab over 60 min.  If tolerated, all subsequent doses of durvalumab can be administered over 30 minutes. 
o If not administered immediately, may be stored (from the time of preparation to the completion of infusion) for up to 28 days refrigerated at 2°C to 8°C (36°F to 46°F). 
o Administer intravenously via a 0.2 to 0.22 micron low protein binding in-line filter. 
o Do not coadminister with other drugs through the same IV line. 
o Flush line with Normal Saline once completed. Do not shake.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DURVALUMAB 50 MG/ML INTRAVENOUS SOLUTION	Medications	1,500 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	220 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 17  (Month 17)	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   
NRG-GI012_Tran[AR1]
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for  Treatment: Refer to 6.
Protocol Access Hyperlink:  
NRG-GI012_Tran[AR1]
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Radiotherapy (SBRT)
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Child Pugh Score. After EOT every 3 months for 2 years , every 6 months for 3 years, then annually
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	mALBI Score. After EOT every 3 months for 2 years ,  every 6 months for 3 years , then annually
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	AE Assessment per CTCAE v5.0a. Up to 18 months from randomization
			Nursing Orders
  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	Please ensure thyroid function tests (TSH, Free T4, and T3) are assessed at least every 4 weeks.
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T3	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Research Labs
  	ONC NURSING COMMUNICATION 73	Interval: --	Occurrences: --	Comments:	WHOLE BLOOD for DNA. As clinically indicated. Pre-treatment: 
If sites miss collection of WB01, then sites can collect at any other visit instead but must comment on Biospecimen Transmittal form and use code (WB02)
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	Notify physician IF
o TSH GREATER than 10 and free T4 LESS than 0.9 or T3 LESS than 80; 
o TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200.
			Nursing Orders
  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1,000; 
o Platelets LESS than 100,000; 
o AST or ALT GREATER than 3x ULN or Total Bilirubin GREATER than 1.5x ULN; 
o Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline.
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Immuno-therapy
  	durvalumab (IMFINZI) 1,500 mg in sodium chloride 0.9% 250 mL (6 mg/mL) IVPB (RESTRICTED)	Dose: 1,500 mg	Route: intravenous	once over 60 Minutes for 1 dose			Offset: 2 Hours	Instructions:	o Administer first dose of durvalumab over 60 min.  If tolerated, all subsequent doses of durvalumab can be administered over 30 minutes. 
o If not administered immediately, may be stored (from the time of preparation to the completion of infusion) for up to 28 days refrigerated at 2°C to 8°C (36°F to 46°F). 
o Administer intravenously via a 0.2 to 0.22 micron low protein binding in-line filter. 
o Do not coadminister with other drugs through the same IV line. 
o Flush line with Normal Saline once completed. Do not shake.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DURVALUMAB 50 MG/ML INTRAVENOUS SOLUTION	Medications	1,500 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	220 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 18  (Month 18)	Repeat 1 time	Cycle length: 28 days	Cycle 18	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   
NRG-GI012_Tran[AR1]
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for  Treatment: Refer to 6.
Protocol Access Hyperlink:  
NRG-GI012_Tran[AR1]
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Radiotherapy (SBRT)
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Child Pugh Score. After EOT every 3 months for 2 years , every 6 months for 3 years, then annually
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	mALBI Score. After EOT every 3 months for 2 years ,  every 6 months for 3 years , then annually
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	AE Assessment per CTCAE v5.0a. Up to 18 months from randomization
			Labs
  	ALPHA FETOPROTEIN	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	Please ensure thyroid function tests (TSH, Free T4, and T3) are assessed at least every 4 weeks.
			Research Labs
  	ONC NURSING COMMUNICATION 73	Interval: --	Occurrences: --	Comments:	WHOLE BLOOD for DNA. As clinically indicated. Pre-treatment: 
If sites miss collection of WB01, then sites can collect at any other visit instead but must comment on Biospecimen Transmittal form and use code (WB02)
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T3	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Imaging
☑	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Multiphasic liver CT and/or multi-phasic liver MRI. After EOT every 3 months for 2 years, every 6 months for 3 years, then annually.
		☑	CT ABDOMEN WWO CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --		☐	MRI ABDOMEN WO CONTRAST	Interval: --	Occurrences: --		☐	CT ABDOMEN PELVIS W WO CONTRAST	Interval: --	Occurrences: --		☐	CT ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --			Imaging
  	CT CHEST W WO CONTRAST	Interval: --	Occurrences: --	Comments:	From end of treatment:every 6 months x 2 years; then annually
(IV contrast preferred, but not required)
			Imaging
☐	CT PELVIS W CONTRAST	Interval: --	Occurrences: --		☐	CT PELVIS WO CONTRAST	Interval: --	Occurrences: --		☐	MRI PELVIS W CONTRAST	Interval: --	Occurrences: --		☐	MRI PELVIS WO CONTRAST	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	Notify physician IF
o TSH GREATER than 10 and free T4 LESS than 0.9 or T3 LESS than 80; 
o TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200.
			Nursing Orders
  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1,000; 
o Platelets LESS than 100,000; 
o AST or ALT GREATER than 3x ULN or Total Bilirubin GREATER than 1.5x ULN; 
o Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline.
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Immuno-therapy
  	durvalumab (IMFINZI) 1,500 mg in sodium chloride 0.9% 250 mL (6 mg/mL) IVPB (RESTRICTED)	Dose: 1,500 mg	Route: intravenous	once over 60 Minutes for 1 dose			Offset: 2 Hours	Instructions:	o Administer first dose of durvalumab over 60 min.  If tolerated, all subsequent doses of durvalumab can be administered over 30 minutes. 
o If not administered immediately, may be stored (from the time of preparation to the completion of infusion) for up to 28 days refrigerated at 2°C to 8°C (36°F to 46°F). 
o Administer intravenously via a 0.2 to 0.22 micron low protein binding in-line filter. 
o Do not coadminister with other drugs through the same IV line. 
o Flush line with Normal Saline once completed. Do not shake.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DURVALUMAB 50 MG/ML INTRAVENOUS SOLUTION	Medications	1,500 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	220 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 19  (Month 19)	Repeat 1 time	Cycle length: 28 days	Cycle 19	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   
NRG-GI012_Tran[AR1]
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for  Treatment: Refer to 6.
Protocol Access Hyperlink:  
NRG-GI012_Tran[AR1]
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Radiotherapy (SBRT)
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Child Pugh Score. After EOT every 3 months for 2 years , every 6 months for 3 years, then annually
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	mALBI Score. After EOT every 3 months for 2 years ,  every 6 months for 3 years , then annually
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	AE Assessment per CTCAE v5.0a. Up to 18 months from randomization
			Nursing Orders
  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	Please ensure thyroid function tests (TSH, Free T4, and T3) are assessed at least every 4 weeks.
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T3	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Research Labs
  	ONC NURSING COMMUNICATION 73	Interval: --	Occurrences: --	Comments:	WHOLE BLOOD for DNA. As clinically indicated. Pre-treatment: 
If sites miss collection of WB01, then sites can collect at any other visit instead but must comment on Biospecimen Transmittal form and use code (WB02)
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	Notify physician IF
o TSH GREATER than 10 and free T4 LESS than 0.9 or T3 LESS than 80; 
o TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200.
			Nursing Orders
  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1,000; 
o Platelets LESS than 100,000; 
o AST or ALT GREATER than 3x ULN or Total Bilirubin GREATER than 1.5x ULN; 
o Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline.
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Immuno-therapy
  	durvalumab (IMFINZI) 1,500 mg in sodium chloride 0.9% 250 mL (6 mg/mL) IVPB (RESTRICTED)	Dose: 1,500 mg	Route: intravenous	once over 60 Minutes for 1 dose			Offset: 2 Hours	Instructions:	o Administer first dose of durvalumab over 60 min.  If tolerated, all subsequent doses of durvalumab can be administered over 30 minutes. 
o If not administered immediately, may be stored (from the time of preparation to the completion of infusion) for up to 28 days refrigerated at 2°C to 8°C (36°F to 46°F). 
o Administer intravenously via a 0.2 to 0.22 micron low protein binding in-line filter. 
o Do not coadminister with other drugs through the same IV line. 
o Flush line with Normal Saline once completed. Do not shake.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DURVALUMAB 50 MG/ML INTRAVENOUS SOLUTION	Medications	1,500 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	220 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 20  (Month 28)	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   
NRG-GI012_Tran[AR1]
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for  Treatment: Refer to 6.
Protocol Access Hyperlink:  
NRG-GI012_Tran[AR1]
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Radiotherapy (SBRT)
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Child Pugh Score. After EOT every 3 months for 2 years , every 6 months for 3 years, then annually
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	mALBI Score. After EOT every 3 months for 2 years ,  every 6 months for 3 years , then annually
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	AE Assessment per CTCAE v5.0a. Up to 18 months from randomization
			Nursing Orders
  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	Please ensure thyroid function tests (TSH, Free T4, and T3) are assessed at least every 4 weeks.
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T3	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Research Labs
  	ONC NURSING COMMUNICATION 73	Interval: --	Occurrences: --	Comments:	WHOLE BLOOD for DNA. As clinically indicated. Pre-treatment: 
If sites miss collection of WB01, then sites can collect at any other visit instead but must comment on Biospecimen Transmittal form and use code (WB02)
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	Notify physician IF
o TSH GREATER than 10 and free T4 LESS than 0.9 or T3 LESS than 80; 
o TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200.
			Nursing Orders
  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1,000; 
o Platelets LESS than 100,000; 
o AST or ALT GREATER than 3x ULN or Total Bilirubin GREATER than 1.5x ULN; 
o Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline.
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Immuno-therapy
  	durvalumab (IMFINZI) 1,500 mg in sodium chloride 0.9% 250 mL (6 mg/mL) IVPB (RESTRICTED)	Dose: 1,500 mg	Route: intravenous	once over 60 Minutes for 1 dose			Offset: 2 Hours	Instructions:	o Administer first dose of durvalumab over 60 min.  If tolerated, all subsequent doses of durvalumab can be administered over 30 minutes. 
o If not administered immediately, may be stored (from the time of preparation to the completion of infusion) for up to 28 days refrigerated at 2°C to 8°C (36°F to 46°F). 
o Administer intravenously via a 0.2 to 0.22 micron low protein binding in-line filter. 
o Do not coadminister with other drugs through the same IV line. 
o Flush line with Normal Saline once completed. Do not shake.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DURVALUMAB 50 MG/ML INTRAVENOUS SOLUTION	Medications	1,500 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	220 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 21  (Month 21)	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   
NRG-GI012_Tran[AR1]
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for  Treatment: Refer to 6.
Protocol Access Hyperlink:  
NRG-GI012_Tran[AR1]
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Radiotherapy (SBRT)
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Child Pugh Score. After EOT every 3 months for 2 years , every 6 months for 3 years, then annually
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	mALBI Score. After EOT every 3 months for 2 years ,  every 6 months for 3 years , then annually
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	AE Assessment per CTCAE v5.0a. Up to 18 months from randomization
			Nursing Orders
  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	Please ensure thyroid function tests (TSH, Free T4, and T3) are assessed at least every 4 weeks.
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T3	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Imaging
☑	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Multiphasic liver CT and/or multi-phasic liver MRI. After EOT every 3 months for 2 years, every 6 months for 3 years, then annually.
		☑	CT ABDOMEN WWO CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --		☐	MRI ABDOMEN WO CONTRAST	Interval: --	Occurrences: --		☐	CT ABDOMEN PELVIS W WO CONTRAST	Interval: --	Occurrences: --		☐	CT ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --			Research Labs
  	ONC NURSING COMMUNICATION 73	Interval: --	Occurrences: --	Comments:	WHOLE BLOOD for DNA. As clinically indicated. Pre-treatment: 
If sites miss collection of WB01, then sites can collect at any other visit instead but must comment on Biospecimen Transmittal form and use code (WB02)
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	Notify physician IF
o TSH GREATER than 10 and free T4 LESS than 0.9 or T3 LESS than 80; 
o TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200.
			Nursing Orders
  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1,000; 
o Platelets LESS than 100,000; 
o AST or ALT GREATER than 3x ULN or Total Bilirubin GREATER than 1.5x ULN; 
o Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline.
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Immuno-therapy
  	durvalumab (IMFINZI) 1,500 mg in sodium chloride 0.9% 250 mL (6 mg/mL) IVPB (RESTRICTED)	Dose: 1,500 mg	Route: intravenous	once over 60 Minutes for 1 dose			Offset: 2 Hours	Instructions:	o Administer first dose of durvalumab over 60 min.  If tolerated, all subsequent doses of durvalumab can be administered over 30 minutes. 
o If not administered immediately, may be stored (from the time of preparation to the completion of infusion) for up to 28 days refrigerated at 2°C to 8°C (36°F to 46°F). 
o Administer intravenously via a 0.2 to 0.22 micron low protein binding in-line filter. 
o Do not coadminister with other drugs through the same IV line. 
o Flush line with Normal Saline once completed. Do not shake.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DURVALUMAB 50 MG/ML INTRAVENOUS SOLUTION	Medications	1,500 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	220 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 22  (Month 22)	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   
NRG-GI012_Tran[AR1]
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for  Treatment: Refer to 6.
Protocol Access Hyperlink:  
NRG-GI012_Tran[AR1]
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Radiotherapy (SBRT)
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Child Pugh Score. After EOT every 3 months for 2 years , every 6 months for 3 years, then annually
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	mALBI Score. After EOT every 3 months for 2 years ,  every 6 months for 3 years , then annually
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	AE Assessment per CTCAE v5.0a. Up to 18 months from randomization
			Nursing Orders
  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	Please ensure thyroid function tests (TSH, Free T4, and T3) are assessed at least every 4 weeks.
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T3	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Research Labs
  	ONC NURSING COMMUNICATION 73	Interval: --	Occurrences: --	Comments:	WHOLE BLOOD for DNA. As clinically indicated. Pre-treatment: 
If sites miss collection of WB01, then sites can collect at any other visit instead but must comment on Biospecimen Transmittal form and use code (WB02)
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	Notify physician IF
o TSH GREATER than 10 and free T4 LESS than 0.9 or T3 LESS than 80; 
o TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200.
			Nursing Orders
  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1,000; 
o Platelets LESS than 100,000; 
o AST or ALT GREATER than 3x ULN or Total Bilirubin GREATER than 1.5x ULN; 
o Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline.
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Immuno-therapy
  	durvalumab (IMFINZI) 1,500 mg in sodium chloride 0.9% 250 mL (6 mg/mL) IVPB (RESTRICTED)	Dose: 1,500 mg	Route: intravenous	once over 60 Minutes for 1 dose			Offset: 2 Hours	Instructions:	o Administer first dose of durvalumab over 60 min.  If tolerated, all subsequent doses of durvalumab can be administered over 30 minutes. 
o If not administered immediately, may be stored (from the time of preparation to the completion of infusion) for up to 28 days refrigerated at 2°C to 8°C (36°F to 46°F). 
o Administer intravenously via a 0.2 to 0.22 micron low protein binding in-line filter. 
o Do not coadminister with other drugs through the same IV line. 
o Flush line with Normal Saline once completed. Do not shake.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DURVALUMAB 50 MG/ML INTRAVENOUS SOLUTION	Medications	1,500 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	220 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 23  (Month 23)	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   
NRG-GI012_Tran[AR1]
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for  Treatment: Refer to 6.
Protocol Access Hyperlink:  
NRG-GI012_Tran[AR1]
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Radiotherapy (SBRT)
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Child Pugh Score. After EOT every 3 months for 2 years , every 6 months for 3 years, then annually
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	mALBI Score. After EOT every 3 months for 2 years ,  every 6 months for 3 years , then annually
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	AE Assessment per CTCAE v5.0a. Up to 18 months from randomization
			Nursing Orders
  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	Please ensure thyroid function tests (TSH, Free T4, and T3) are assessed at least every 4 weeks.
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T3	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Research Labs
  	ONC NURSING COMMUNICATION 73	Interval: --	Occurrences: --	Comments:	WHOLE BLOOD for DNA. As clinically indicated. Pre-treatment: 
If sites miss collection of WB01, then sites can collect at any other visit instead but must comment on Biospecimen Transmittal form and use code (WB02)
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	Notify physician IF
o TSH GREATER than 10 and free T4 LESS than 0.9 or T3 LESS than 80; 
o TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200.
			Nursing Orders
  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1,000; 
o Platelets LESS than 100,000; 
o AST or ALT GREATER than 3x ULN or Total Bilirubin GREATER than 1.5x ULN; 
o Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline.
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Immuno-therapy
  	durvalumab (IMFINZI) 1,500 mg in sodium chloride 0.9% 250 mL (6 mg/mL) IVPB (RESTRICTED)	Dose: 1,500 mg	Route: intravenous	once over 60 Minutes for 1 dose			Offset: 2 Hours	Instructions:	o Administer first dose of durvalumab over 60 min.  If tolerated, all subsequent doses of durvalumab can be administered over 30 minutes. 
o If not administered immediately, may be stored (from the time of preparation to the completion of infusion) for up to 28 days refrigerated at 2°C to 8°C (36°F to 46°F). 
o Administer intravenously via a 0.2 to 0.22 micron low protein binding in-line filter. 
o Do not coadminister with other drugs through the same IV line. 
o Flush line with Normal Saline once completed. Do not shake.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DURVALUMAB 50 MG/ML INTRAVENOUS SOLUTION	Medications	1,500 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	220 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 24  (Month 24)	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   
NRG-GI012_Tran[AR1]
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for  Treatment: Refer to 6.
Protocol Access Hyperlink:  
NRG-GI012_Tran[AR1]
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Radiotherapy (SBRT)
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Child Pugh Score. After EOT every 3 months for 2 years , every 6 months for 3 years, then annually
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	mALBI Score. After EOT every 3 months for 2 years ,  every 6 months for 3 years , then annually
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	AE Assessment per CTCAE v5.0a. Up to 18 months from randomization
			Nursing Orders
  	ONC NURSING COMMUNICATION 65	Interval: --	Occurrences: --	Comments:	Please ensure thyroid function tests (TSH, Free T4, and T3) are assessed at least every 4 weeks.
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T3	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Labs
  	ALPHA FETOPROTEIN	Interval: --	Occurrences: --			Imaging
☑	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Multiphasic liver CT and/or multi-phasic liver MRI. After EOT every 3 months for 2 years, every 6 months for 3 years, then annually.
		☑	CT ABDOMEN WWO CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --		☐	MRI ABDOMEN WO CONTRAST	Interval: --	Occurrences: --		☐	CT ABDOMEN PELVIS W WO CONTRAST	Interval: --	Occurrences: --		☐	CT ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --			Imaging
  	CT CHEST W WO CONTRAST	Interval: --	Occurrences: --	Comments:	From end of treatment:every 6 months x 2 years; then annually
(IV contrast preferred, but not required)
			Imaging
☐	CT PELVIS W CONTRAST	Interval: --	Occurrences: --		☐	CT PELVIS WO CONTRAST	Interval: --	Occurrences: --		☐	MRI PELVIS W CONTRAST	Interval: --	Occurrences: --		☐	MRI PELVIS WO CONTRAST	Interval: --	Occurrences: --			Research Labs
  	ONC NURSING COMMUNICATION 73	Interval: --	Occurrences: --	Comments:	WHOLE BLOOD for DNA. As clinically indicated. Pre-treatment: 
If sites miss collection of WB01, then sites can collect at any other visit instead but must comment on Biospecimen Transmittal form and use code (WB02)
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Nursing Orders
  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1,000; 
o Platelets LESS than 100,000; 
o AST or ALT GREATER than 3x ULN or Total Bilirubin GREATER than 1.5x ULN; 
o Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline.
			Nursing Orders
  	TREATMENT CONDITIONS 12	Interval: --	Occurrences: --	Comments:	Notify physician IF
o TSH GREATER than 10 and free T4 LESS than 0.9 or T3 LESS than 80; 
o TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200.
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Immuno-therapy
  	durvalumab (IMFINZI) 1,500 mg in sodium chloride 0.9% 250 mL (6 mg/mL) IVPB (RESTRICTED)	Dose: 1,500 mg	Route: intravenous	once over 60 Minutes for 1 dose			Offset: 2 Hours	Instructions:	o Administer first dose of durvalumab over 60 min.  If tolerated, all subsequent doses of durvalumab can be administered over 30 minutes. 
o If not administered immediately, may be stored (from the time of preparation to the completion of infusion) for up to 28 days refrigerated at 2°C to 8°C (36°F to 46°F). 
o Administer intravenously via a 0.2 to 0.22 micron low protein binding in-line filter. 
o Do not coadminister with other drugs through the same IV line. 
o Flush line with Normal Saline once completed. Do not shake.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DURVALUMAB 50 MG/ML INTRAVENOUS SOLUTION	Medications	1,500 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	220 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
End of Treatment	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   
NRG-GI012_Tran[AR1]
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for  Treatment: Refer to 6.
Protocol Access Hyperlink:  
NRG-GI012_Tran[AR1]
			Nursing Orders
  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Child Pugh Score. After EOT every 3 months for 2 years , every 6 months for 3 years, then annually
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	mALBI Score. After EOT every 3 months for 2 years ,  every 6 months for 3 years , then annually
			Imaging
☑	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Multiphasic liver CT and/or multi-phasic liver MRI. After EOT every 3 months for 2 years, every 6 months for 3 years, then annually.
		☑	CT ABDOMEN WWO CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --		☐	MRI ABDOMEN WO CONTRAST	Interval: --	Occurrences: --		☐	CT ABDOMEN PELVIS W WO CONTRAST	Interval: --	Occurrences: --		☐	CT ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --			Labs
  	ALPHA FETOPROTEIN	Interval: --	Occurrences: --			Imaging
  	CT CHEST W WO CONTRAST	Interval: --	Occurrences: --	Comments:	From end of treatment:every 6 months x 2 years; then annually
(IV contrast preferred, but not required)
			Imaging
☐	CT PELVIS W CONTRAST	Interval: --	Occurrences: --		☐	CT PELVIS WO CONTRAST	Interval: --	Occurrences: --		☐	MRI PELVIS W CONTRAST	Interval: --	Occurrences: --		☐	MRI PELVIS WO CONTRAST	Interval: --	Occurrences: --					
Follow Up	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   
NRG-GI012_Tran[AR1]
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for  Treatment: Refer to 6.
Protocol Access Hyperlink:  
NRG-GI012_Tran[AR1]
			Nursing Orders
  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Child Pugh Score. After EOT every 3 months for 2 years , every 6 months for 3 years, then annually
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	mALBI Score. After EOT every 3 months for 2 years ,  every 6 months for 3 years , then annually
			Imaging
☑	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Multiphasic liver CT and/or multi-phasic liver MRI. After EOT every 3 months for 2 years, every 6 months for 3 years, then annually.
		☑	CT ABDOMEN WWO CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --		☐	MRI ABDOMEN WO CONTRAST	Interval: --	Occurrences: --		☐	CT ABDOMEN PELVIS W WO CONTRAST	Interval: --	Occurrences: --		☐	CT ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --			Labs
  	ALPHA FETOPROTEIN	Interval: --	Occurrences: --			Imaging
  	CT CHEST W WO CONTRAST	Interval: --	Occurrences: --	Comments:	From end of treatment:every 6 months x 2 years; then annually
(IV contrast preferred, but not required)
			Imaging
☐	CT PELVIS W CONTRAST	Interval: --	Occurrences: --		☐	CT PELVIS WO CONTRAST	Interval: --	Occurrences: --		☐	MRI PELVIS W CONTRAST	Interval: --	Occurrences: --		☐	MRI PELVIS WO CONTRAST	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	PLASMA. 
During Treatment:
C1D1 of immunotherapy (PB02)
C3D1 of immunotherapy (PB03)
Post-treatment: (PB04)
Within 14 days of documented radiographic disease progression