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

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.

Timeline

Start

2023-09-21

Primary completion

2026-12

Completion

2026-12

Outcome

Met primary endpoint

release “这是全球第二、国内首个在胆道癌领域取得阳性结果的IDH1抑制剂III期研究。” cttq.com ↗

release “研究结果显示，与安慰剂相比，TQB3454可显著降低患者的疾病进展或死亡风险，无进展生存期 (PFS) 和总生存期 (OS) 均获得显著延长” cttq.com ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	TQB3454	Small molecule	—	Oral

Indications