Overview

This is a prospective, open label, multi-center, interventional study to assess the safety and efficacy of Druvalumab plus Tremelimumab as first-line treatment in Chinese patients with unresectable hepatocellular carcinoma.

Eligibility

Inclusion Criteria:

• Confirmed HCC based on histopathological findings from tumor tissue or radiologically findings
• No prior systemic therapy for HCC
• Barcelona Clinic Liver Cancer (BCLC) stage B (not eligible for locoregional therapy) or stage C
• Child-Pugh Score class A or B
• ECOG performance status (PS) of 0-2 at enrollment (Child-Pugh Score class A and ECOG PS of 0-1 will be enrolled in cohort 1 and Child-Pugh Score class B or ECOG PS of 2 will be enrolled in cohort 2)
• At least 1 measurable lesion per RECSIT 1.1 guidelines

Exclusion Criteria:

• Hepatic encephalopathy within past 12 months or requirement for medication to prevent or control encephalopathy
• Clinically meaningful ascites
• Main portal vein tumor thrombosis
• Active or prior documented GI bleeding (eg, esophageal varices or ulcer bleeding) within 6 months
• HBV and HVC co-infection, or HBV and Hep D co-infection