A Study of Tislelizumab Versus Sorafenib in Participants With Unresectable Hepatocellular Carcinoma (HCC)

Inclusion Criteria

• Histologically confirmed diagnosis of HCC
• Barcelona Clinic Liver Cancer (BCLC) Stage B or C disease not amenable to or progressing after loco-regional therapy and not amenable to a curative treatment approach
• No prior systemic therapy for HCC (with the exception of HCC participants enrolled in the safety run-in substudy [Japan only])
• Measurable disease
• Child-Pugh score A
• Easter Cooperative Oncology Group (ECOG) Performance Status ≤ 1
• Adequate organ function Main Study Key

Exclusion Criteria

• Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC histology
• Tumor thrombus involving main trunk of portal vein or inferior vena cava
• Loco-regional therapy to the liver within 28 days before randomization
• Clinical evidence of portal hypertension with bleeding esophageal or gastric varices at Screening, or within 6 months before randomization
• Bleeding or thrombotic disorder or any prescribed anticoagulant requiring therapeutic international normalized ratio monitoring (eg, warfarin or similar agents) at Screening, or within 6 months before randomization/enrollment
• Presence at Screening of active immune deficiency or autoimmune disease and/or prior history of any immune deficiency or autoimmune disease that may relapse
• Participant with any condition requiring systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication within 14 days before randomization
• History of interstitial lung disease or non-infectious pneumonitis, unless induced by radiation therapy
• QT interval corrected for heart rate (QTc) (corrected by Fridericia's method) > 450 msec at Screening NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.