Protocol Index	

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OP RESEARCH PRO00038278 / DURVALUMAB / BEVACIZUMAB SCREENING / BASELINE	

Types:      Research Oncology Treatment
Synonyms:  PRE-SCREENING, BASELINE

Screening	Repeat 1 time	Cycle length: 28 days	Day -28 to -1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Participants will receive a single dose of durvalumab 1500 mg via IV infusion starting no earlier than 14 (+ 3) days after the TARE procedure. Participants will then receive durvalumab 1120 mg q3w + bevacizumab 15 mg/kg 14 (+ 3) days after single dose of durvalumab. In the event bevacizumab cannot be tolerated, durvalumab may be continued as monotherapy.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Key Inclusion criteria:
·      Confirmed HCC by imaging with no evidence of extrahepatic disease on any available imaging
·      Child-Pugh score class A
·      ECOG of 0 or 1 at enrollment
·      Hemoglobin >= 9.0 g/dL
·      Absolute neutrophil count >= 1000/uL
·      Platelet count >= 75000/uL
·      Total bilirubin <= 2 × ULN
·      (e) ALT and AST <= 5 × ULN
·      (f) Albumin >= 2.8 g/dL
·      (g) INR <= 1.6
·      (h) 2+ proteinuria or less urine dipstick reading. Participants having > 2+ proteinuria on
·      urine dipstick testing will undergo 24-hour urine collection for quantitative
·      assessment of proteinuria. Participants with urine protein >= 1 g/24 hours will be
·      ineligible.
·      CrCL >= 30 mL/min as determined by Cockcroft-Gault (using actual body weight) or
·      24-hour urine creatinine CL
·      Body weight > 30 kg.
·      HBV and HCV permitted
·      Ascites: stable dose of diuretics for at least 2 months
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Key Exclusion criteria:
·      Fibrolamellar, sarcomatoid or mixed cholangiocarcinoma and HCC
·      Uncontrolled systemic disease 
·      HBV and HDV co-infection, HIV positive or positive test for TB
·      Evidence of pulmonary insufficiency or COPD
·      Nephrotic/nephritic syndrome, autoimmune or inflammatory disorders
·      Clinically significant cardiovascular disease
·      Variceal bleed within 6 months of study intervention 
·      History of arterial thrombotic event within 6 months prior to enrollment
·      Major surgery within past 28 days
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Full Physical exam
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	ECOG
		  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	RESEARCH - HEIGHT AND WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Child-Pugh score: Assess cirrhosis severity, as determined by the Child-Pugh score
			Procedures
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Electrocardiography (ECG) will be performed at screening and when clinically indicated
		  	EGD-EXTERNAL	Interval: --	Occurrences: --	Comments:	Upper endoscopy for varices and bleeding risk (6 months prior to enrollment)
		  	CT CHEST W WO CONTRAST ABDOMEN W CONTRAST	Interval: --	Occurrences: --	Comments:	HCC liver lesions evaluated by mRECIST mandate the acquisition of arterial phase and portal venous phase IV contrast-enhanced MRI scans of the liver (abdomen).
			Labs
☑	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --		☑	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --		☑	HIV 1/2 ANTIGEN/ANTIBODY, FOURTH GENERATION, WITH REFLEXES	Interval: --	Occurrences: --		☑	TB SKIN TEST	Interval: --	Occurrences: --		☑	ALPHA FETOPROTEIN	Interval: --	Occurrences: --		☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	AMYLASE LEVEL	Interval: --	Occurrences: --		☑	GGT	Interval: --	Occurrences: --		☑	LDH	Interval: --	Occurrences: --		☑	LIPASE LEVEL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --		☑	TSH WITH REFLEX TO FREE T4	Interval: --	Occurrences: --	Comments:	If TSH is abnormal or if there is clinical suspicion of new symptom/side effect related to the endocrine system collect T3 free (reflex) or T4 free (reflex)..
		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	PT AND PTT	Interval: --	Occurrences: --		☑	ACUTE VIRAL HEPATITIS PANEL (HAV, HBV, HCV)	Interval: --	Occurrences: --		☑	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --					
Baseline	Repeat 1 time	Cycle length: 28 days	Day 0	Perform every 1 day x1		Procedures
  	CT CHEST W WO CONTRAST ABDOMEN W CONTRAST	Interval: --	Occurrences: --		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Electrocardiography (ECG) will be performed at screening and when clinically indicated
			Labs
☑	HIV 1/2 ANTIGEN/ANTIBODY, FOURTH GENERATION, WITH REFLEXES	Interval: --	Occurrences: --		☑	ALPHA FETOPROTEIN	Interval: --	Occurrences: --		☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	AMYLASE LEVEL	Interval: --	Occurrences: --		☑	GGT	Interval: --	Occurrences: --		☑	LDH	Interval: --	Occurrences: --		☑	LIPASE LEVEL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --		☑	TSH WITH REFLEX TO FREE T4	Interval: --	Occurrences: --	Comments:	If TSH is abnormal or if there is clinical suspicion of new symptom/side effect related to the endocrine system collect T3 free (reflex) or T4 free (reflex).
		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	PT AND PTT	Interval: --	Occurrences: --		☑	ACUTE VIRAL HEPATITIS PANEL (HAV, HBV, HCV)	Interval: --	Occurrences: --		☑	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --