Durvalumab and Tremelimumab With Lenvatinib as First-line Treatment in Patients With Unresectable Hepatocellular Carcinoma

An Open-label, Multi-center Phase II Study of Durvalumab and Tremelimumab With Lenvatinib as First-line Treatment in Patients With Unresectable Hepatocellular Carcinoma

This is a Phase II, single-arm, multicentre study, assessing the efficacy and safety of durvalumab and tremelimumab with lenvatinib in participants with unresectable HCC.

Inclusion Criteria:

• Confirmed HCC based on histopathological findings from tumor tissues or radiologically findings.
• Must not have received prior systemic therapy for unresectable HCC.
• Barcelona Clinic Liver Cancer (BCLC) stage B (that is not eligible for locoregional therapy) or stage C.
• Child-Pugh Score class A.
• ECOG performance status of 0 or 1 at enrollment.
• At least 1 measurable lesion per RECSIT 1.1 guidelines

Exclusion Criteria:

• Any unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) Grade ≥2 from previous anticancer therapy.
• History of hepatic encephalopathy within past 12 months or requirement for medications to prevent or control encephalopathy.
• Clinically meaningful ascites.
• Patients with main portal vein thrombosis.
• Active or prior documented GI bleeding.
• Patient currently exhibits symptomatic or uncontrolled hypertension.
• Patients co-infected with HBV and HCV, or co-infected with HBV and hepatitis D virus (HDV)
• Uncontrolled intercurrent illness