Trials / Active Not Recruiting
Active Not RecruitingNCT05987358
A Clinical Study of TQB3454 Tablets in the Treatment of Advanced Biliary Carcinoma.
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.
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 165 (estimated)
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TQB3454 tablets | TQB3454 is a selective IDH1 mutant enzyme inhibitor. |
| DRUG | TQB3454 tablets matching placebo | Placebo tablets without active substance. |
Timeline
- Start date
- 2023-09-21
- Primary completion
- 2026-12-01
- Completion
- 2026-12-01
- First posted
- 2023-08-14
- Last updated
- 2026-03-11
Locations
6 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05987358. Inclusion in this directory is not an endorsement.