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 range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall survival (OS)
Timeframe: Up to 18 months.
Trial details
NCT IDNCT05987358
SponsorChia Tai Tianqing Pharmaceutical Group Co., Ltd.
. 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;
. Those who plan to undergo or have previously received allogeneic bone marrow transplantation or solid organ transplantation;