RATIONALE-301 | BGB-A317-301

TislelizumabHCCPhase 3Completed

Summary

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 ArmPopulationInterventionComparisonOutcome

Previously untreated, unresectable HCC


Tislelizumab


Sorafenib


Primary Endpoint: OS


Key Secondary Endpoints: ORR, PFS, DoR, TTP


Phase III RATIONALE trial design comparing tislelizumab vs sorafenib in liver cancer

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