Durvalumab and Lenvatinib in Participants With Locally Advanced and Metastatic Hepatocellular Carcinoma ( Dulect2020-1 )

Inclusion Criteria

• •Patients must have pathologically or cytologically or by radiological criteria proven hepatocellular carcinoma; known mixed histology (e.g. hepatocellular carcinoma plus cholangiocarcinoma) or fibrolamellar variant is not allowed
• •Locally advanced and metastatic HCC
• •Has an eligibility scan (CT of the chest, triphasic CT scan or MRI of the abdomen, and CT or MRI of the pelvis) \<1 week before the treatment of durvalumab in combination with lenvatinib.
• •Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days prior to Cycle 1, Day 1.
• •Has a Child-Pugh A liver score (5 to 6 points) within 7 days prior to Cycle1, Day 1.
• •Has controlled hepatitis B (Hep B)
• •The estimate time length between enrollment and liver transplantation should be at least 2 months
• •No prior systemic therapy, local therapy (TACE etc.)\>6w
• •If female, is not pregnant or breastfeeding, and at least one of the following conditions applies: 1) Is not a woman of childbearing potential (WOCBP); or 2) Is a WOCBP and using a contraceptive method that is highly effective or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (a WOCBP must have a negative pregnancy test within 72 hours before the first dose of study treatment).
• •Has adequate organ function.
• •Granulocytes \>= 1,500/uL
• •Hemoglobin \>= 8.5 g/dL; patients with recent or ongoing gastrointestinal bleed may not be transfused to reach the entry hemoglobin of 8.5 g/dL; physicians should ensure patients requiring transfusion prior to registration do not have an occult or clinically apparent gastrointestinal bleed
• •Platelets \>= 75,000/uL
• •Creatinine =\< 1.5 x upper limit of normal (ULN) (or creatinine clearance calculated \>= 60 cc/minute)
• •Bilirubin =\< 3 mg/dL
• •Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\<5 x ULN
• •Prothrombin time (PT)-international normalized ratio (INR) =\< 1.7 (not required for patients on anticoagulation agents; patients who are being therapeutically anticoagulated with an agent such as Coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists)
• •Patients with a history of hypertension should be well controlled (\< 140/90 mmHg) on a regimen of anti-hypertensive therapy
• •Significant history of cardiac disease is not allowed:
• •Congestive heart failure \> class II New York Heart Association (NYHA) Myocardial infarction within 6 months prior to registration Serious myocardial dysfunction, defined as scintigraphically (multigated acquisition scan \[MUGA\], myocardial scintigram) determined absolute left ventricular ejection fraction (LVEF) below 45% or an LVEF on echocardiogram(ECHO) below the normal limit at the individual institution