A Clinical Study of TQB3454 Tablets in the Treatment of Advanced Biliary Carcinoma. (NCT05987358) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Clinical Study of TQB3454 Tablets in the Treatment of Advanced Biliary Carcinoma.
China165 participantsStarted 2023-09-21
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. cholangiocarcinoma histologically or cytologically confirmed
✓. Locally advanced, relapsing, and/or metastatic disease that is not operable and has at least one measurable lesion according to Response Evaluation Criteria In Solid Tumors V1.1 (RECIST 1.1) criteria.
✓. Previous gemcitabine and fluorouracil (and/or platinum-based) drug therapy failed.
Exclusion criteria
✕. The patient had or was currently present with other malignant tumors within 3 years prior to the first medication.
✕. Unmitigated toxic reactions above class 1 of Common Terminology Criteria for Adverse Events V5.0 (CTCAE) due to any previous treatment, excluding hair loss;
✕. Received major surgical treatment, significant traumatic injury, or long-standing unhealed wounds or fractures within 4 weeks prior to initial medication;
✕. Patients with any bleeding or bleeding events ≥CTCAE grade 3 within 4 weeks prior to initial administration; Patients with arteriovenous thrombotic events, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis and pulmonary embolism, occurring within 6 months prior to initial administration; Treatment with low molecular weight heparin was allowed and antiplatelet drugs were prohibited throughout the study;
✕. There is a history of active tuberculosis, idiopathic pulmonary fibrosis, institutional pneumonia, drug-induced pneumonia, radiation pneumonia requiring treatment or active pneumonia with clinical symptoms;
✕. Those who have the history of psychotropic drug abuse and cannot abstain or have mental disorders;
What they're measuring
1
Overall survival (OS)
Timeframe: Up to 18 months.
Trial details
NCT IDNCT05987358
SponsorChia Tai Tianqing Pharmaceutical Group Co., Ltd.