A Randomized, Open-label, Multicenter Phase 3 Study to Compare the Efficacy and Safety of BGB-A317 Versus Sorafenib as First-Line Treatment in Patients With Unresectable Hepatocellular Carcinoma
A Randomized, Open-label, Multicenter Phase 3 Study to Compare the Efficacy and Safety of BGB-A317 Versus Sorafenib as First-Line Treatment in Patients With Unresectable Hepatocellular Carcinoma
This Phase 3 study was a global, multicenter trial that randomly assigned participants to either tislelizumab or sorafenib as a first-line treatment for adults with advanced liver cancer (hepatocellular carcinoma) that could not be surgically removed. Before enrolling Japanese participants in the main Phase 3 study, a preliminary assessment of safety and tolerability (the Safety Run-In Sub-study) was conducted in Japan.
Safety Run-In Sub-study Eligibility Criteria: The study included adult Japanese participants (≥ 20 years) with histologically confirmed hepatocellular carcinoma (HCC) at Barcelona Clinic Liver Cancer (BCLC) Stage C or B. Eligible participants had either received, were ineligible for, or declined standard treatment. Additional requirements were a Child-Pugh A classification within 7 days before enrollment, at least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, and an Eastern Cooperative Oncology Group (ECOG) Performance Status score of ≤ 1.
Main Study Key Inclusion Criteria:
Main Study Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Chongqing, Chongqing Municipality 630014, China
Wuhan, Hubei 430022, China
Hangzhou, Zhejiang 310003, China
Fukuokacity, Fukuoka 810-8563, Japan
Nishinomiyashi, Hyōgo 663-8501, Japan
Yahabacho Shiwagun, Iwate 028-3695, Japan
Yokohama, Kanagawa 232-0024, Japan
Ōmura, Nagasaki 856-8562, Japan
Osakashi, Osaka 540-0006, Japan
Osakashi, Osaka 541-8567, Japan
Suitashi, Osaka 565-0871, Japan
Bunkyoku, Tokyo 1138655, Japan
Itabashiku, Tokyo 173-8610, Japan
Shibuyaku, Tokyo 150-8935, Japan
Shinjukuku, Tokyo 162-8655, Japan
Warsaw, 02-034, Poland
Greater Manchester, M20 4BX, United Kingdom