Neoplasms

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Rare Diseases

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Biliary Tract Cancer

All Drugs and Chemicals

Enzyme Inhibitors

TQB3454 tablets orally administered, 21 days as a treatment cycle.

Placebo tablets orally administered, 21 days as a treatment cycle.

TQB3454 is a selective IDH1 mutant enzyme inhibitor.

TQB3454 tablets

Placebo tablets without active substance.

TQB3454 tablets matching placebo

Lin Shen, Doctor of Medicine

Zhongtao Zhang, Doctor

Wence Zhou, Doctor

Zhiwu Wang, Doctor

Feng Shen, Doctor of Medicine

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.

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.

It refers to the time from randomization to the death from any cause.

It refers to the time from randomization to disease progression or death, whichever occurs first.

The time between the first disease progression and the second disease progression or death, whichever comes first.

The percentage of subjects with complete response (CR) or partial response (PR).

The percentage of subjects with complete response (CR), partial response (PR) and stable disease (SD).

The time from randomization to initiation of a new antitumor therapy or early termination of therapy.

It is an integrated system to describe the quality of life of cancer patients.

The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs) as assessed by Common Terminology Criteria for Adverse Events V5.0 (CTCAE 5.0)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Clinical Study of TQB3454 Tablets in the Treatment of Advanced Biliary Carcinoma.	NCT05987358	Biliary Carcino...	TQB3454 tablets TQB3454 tablets...	18 Years - 75 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
A Clinical Study of TQB3454 Tablets in the Treatment of Advanced Biliary Carcinoma.	NCT05987358	Biliary Carcino...	TQB3454 tablets TQB3454 tablets...	18 Years - 75 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Spots Global Cancer Trial Database for tqb3454 tablets matching placebo