This study is a randomized, controlled, open-label, multicenter, seamless Phase II/III trial designed to evaluate the efficacy and safety of the combination regimen of IBI310 and sintilimab in participants with locally advanced or metastatic hepatocellular carcinoma (HCC) who are: (1) treatment-naive to systemic therapy; and (2) either unsuitable for curative-intent surgical resection or local therapy, or have experienced disease progression following prior surgical resection or local therapy.
Histologically or cytologically confirmed hepatocellular carcinoma (HCC).
Age ≥18 years and ≤75 years.
Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1.
Barcelona Clinic Liver Cancer (BCLC) staging of Stage C, or Stage B that is unsuitable for curative-intent surgery and/or locoregional therapy.
Histologically or cytologically confirmed diagnosis of fibrolamellar hepatocellular carcinoma (HCC), sarcomatoid HCC, cholangiocarcinoma, or other mixed hepatic malignancies containing these components.
History of hepatic encephalopathy or prior liver transplantation.
Clinically symptomatic pleural effusion, ascites, or pericardial effusion requiring therapeutic drainage; participants with only minimal (radiologically detected), asymptomatic effusions may be enrolled.
Known central nervous system (CNS) metastases or symptomatic spinal cord compression.