Biliary Carcinoma Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Study to Evaluate the Efficacy and Safety of TQB3454 Tablets in the Treatment of Advanced Biliary Tract Cancer With Isocitrate Dehydrogenase 1 (IDH1) Mutation.
This study used a randomized, controlled, double-blind, multicenter Phase III clinical design with overall survival (OS) as the primary endpoint. About 165 patients with advanced biliary carcinoma were enrolled and randomly assigned to the experimental group and the control group in a 2:1 ratio to receive TQB3454 tablets or the placebo, respectively, to evaluate the efficacy and safety of TQB3454 tablets in the treatment of advanced biliary carcinoma.
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