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A Clinical Study of TQB3454 Tablets in the Treatment of Advanced Biliary Carcinoma.

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Not Yet Recruiting to Active, Not Recruiting Start date changed from estimate of Oct 2023 to Sep 21, 2023 · Site contacts updated at 5 of 6 sitesv2 Show 2 more changesShow less
    • Start date changed from estimate of Oct 2023 to Sep 21, 2023
    • Site contacts updated at 5 of 6 sites
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05987358
Lead Sponsor Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Conditions Biliary Carcinoma
Enrollment 165 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov