Spots Global Cancer Trial Database for A Clinical Study of TQB3454 Tablets in the Treatment of Advanced Biliary Carcinoma.
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Trial Identification
Brief Title: A Clinical Study of TQB3454 Tablets in the Treatment of Advanced Biliary Carcinoma.
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.
Study ID: NCT05987358
Conditions
Study Description
Brief Summary: 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Beijing Friendship Hospital, Capital Medical University, Beijing, Beijing, China
Beijing Cancer Hospital, Beijing, Beijing, China
Lanzhou University Second Hospital, Lanzhou, Gansu, China
Tangshan People's Hospital, Tangshan, Hebei, China
Third Affiliated Hospital of Naval Medical University, Shanghai, Shanghai, China
Tianjin Medical University Cancer Institute & Hospital, Tianjin, Tianjin, China
Contact Details
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