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OP RSH PRO00041696  ABDELRAHIM RP2 COHORT 2 HEPATOCELLULAR CARCINOMA SCREENING	

Types:      Research Oncology Treatment
Synonyms:  UNRESECTABLE, RECURRENT, METASTATIC

Screening	Repeat 1 time	Cycle length: 28 days	Day -1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	Nursing: Protocol Hyperlink: 
-  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.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Informed consent
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Inclusion and exclusion criteria review
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Demography
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Medical history
-  Includes past and current significant medical conditions, any history of herpetic infections, and a detailed oncologic history, including history of any surgeries or radiation therapy.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Child-Pugh score
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Full physical examination
- Includes height (at Screening only) and weight (at any time point described).
		  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --	Comments:	Includes height (at Screening only) and weight (at any time point described).
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital signs include sitting blood pressure, resting pulse, respiratory rate, body temperature, and pulse oximetry at screening and whenever clinically  indicated.
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	ECOG performance status
			Imaging
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	To be performed before treatment with study drugs at the indicated timepoints during both courses of RP2 and as clinically indicated, including during follow-up visits.
			Nursing Orders
  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Adverse Event (AE) / Serious Adverse Event (SAE) review.SAEs will begin to be documented starting with the signing of the ICF. AEs will begin to be documented starting with the first dose of study treatment.
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	Central and local laboratory. Local laboratory results will be used at Screening for eligibility at times when/if central laboratory results are unable to be obtained in time. Local laboratory testing before dosing may be used for treatment decisions or for acute patient management. Labs may be done up to 3 days prior to dosing.
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	Prior and concomitant medications
- Prior and concomitant medications will begin to be documented starting with the signing of the ICF.
			Labs
  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Hematology, Chemistry, Coagulation 
Local laboratory results will be used at Screening for eligibility at times when/if central laboratory results are unable to be obtained in time. Local laboratory testing before dosing may be used for treatment decisions or for acute patient management. Labs may be done up to 3 days prior to dosing.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --			Labs
  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Pregnancy Tests
-  A serum hCG pregnancy test will be performed for all women of child-bearing potential at screening LESS than or EQUAL 72 hours before the first study treatment. 
-  A urine pregnancy test will also be performed for all women of child-bearing potential at all other specified time points, including before administration of study treatment. 
-  If the urine test at any time point is positive, a serum pregnancy test will be done by the local laboratory for confirmation.
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential.
			Labs
  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Hepatitis B and C Serology
Hepatitis serology tests will be run locally. If a patient has a positive HBsAg test and/or a positive total HBcAb test at Screening, HBV DNA test should be
performed at Screening. Similarly, if a patient has a positive HCV antibody test at Screening, HCV RNA test is required to determine if the patient has an active HCV infection. Only if a patient tests positive at Screening, quantitative HBV DNA, and HCV RNA will need to be tested subsequently at Week 7 Day 43, Week 15 Day 99, and at treatment discontinuation (EOT).
			Labs
  	HEPATITIS B SURFACE ANTIGEN	Interval: --	Occurrences: --		  	HEPATITIS B CORE ANTIBODY TOTAL	Interval: --	Occurrences: --		  	HEPATITIS B SURFACE ANTIBODY	Interval: --	Occurrences: --			Labs
  	HEPATITIS C VIRUS (HCV) ANTIBODY WITH REFLEX TO PCR	Interval: --	Occurrences: --			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T3, FREE	Interval: --	Occurrences: --	Comments:	Free T3 and free T4 will only be measured if TSH is abnormal.
		  	T4, FREE	Interval: --	Occurrences: --	Comments:	Free T3 and free T4 will only be measured if TSH is abnormal.
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Amylase, lipase (central laboratory)
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Chemistry, hematology, coagulation (central laboratory)
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	-  Whole blood must be collected and shipped on the day of collection. 
-  These samples may be collected up to 3 days before the visit to ensure delivery to the laboratory to allow for processing during normal business hours. 
-  Alternatively, the Sponsor may agree to selected centers processing whole blood locally. 
-  Instructions for each will be provided in a Laboratory Manual.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	-  Blood samples for plasma are collected at Screening, during Week 1 (Day 1 (pre dose), Day 2, and Day 3), Week 3 (Day 15 (pre dose), Day 16 and Day 17) and at pre dose during Week 7 Day 43, Week 13 Day 85, Week 19 Day 127, and End of Treatment. 
-  Blood samples should be collected at disease progression, complete response, and for suspected cytokine-release syndrome-like event. 
-  Please refer to Laboratory Manual for additional instructions.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Predose on Day 29
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Collect before RP2 dosing and only during the first course of RP2.
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Imaging
  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Imaging and Tumor Assessments
Must include chest, abdomen, pelvis as well as any other areas of disease at both screening and follow-up. When using CT, all abdominal CTs must be 3 or 4 phase. A radiographic scan and assessment should be performed at least 4 to 8 weeks from initial Investigator assessed progression to determine whether there has been continued progressive disease (refer to Appendix E and Appendix F for imaging and assessment guidelines). A biopsy may be used to confirm the response status of individual lesions. The same imaging modality that was used for a patient's baseline assessment must be used throughout the study.
All tumors selected for injection will be measured with ultrasound, CT or MRI imaging to determine the volume of RP2 to be injected.
		  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI
		  	MRI CHEST W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		  	MRI ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT
		  	MRI PELVIS W CONTRAST	Interval: 1 time imaging	Occurrences: --	Comments:	Or CT