RATIONALE-306 | BGB-A317-306

TislelizumabESCCPhase 3Completed

Summary

The purpose of this study is to evaluate the efficacy and safety of tislelizumab as first line treatment in combination with chemotherapy in participants with advanced unresectable/metastatic esophageal squamous cell carcinoma (ESCC).

Study ArmPopulationInterventionComparisonOutcome

Previously untreated advanced unresectable/metastatic ESCC


Tislelizumab + Investigator-chosen chemotherapy


Placebo + Investigator-chosen chemotherapy


Primary Endpoints: OS (ITT population)


Key Secondary Endpoints: PFS, ORR, and DoR by investigator, OS in the PD-L1 score ≥10% subgroup, HRQoL, safety


Phase III RATIONALE trial design evaluating tislelizumab as first line treatment with chemotherapy in advanced or metastatic ESCC

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