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.
| Study Arm | Population | Intervention | Comparison | Outcome |
|---|---|---|---|---|
Previously untreated, unresectable HCC |
Tislelizumab |
Sorafenib |
Primary Endpoint: OS Key Secondary Endpoints: ORR, PFS, DoR, TTP |