- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05987358
A Clinical Study of TQB3454 Tablets in the Treatment of Advanced Biliary Carcinoma.
August 4, 2023 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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.
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
165
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lin Shen, Doctor of Medicine
- Phone Number: +86 13911219511
- Email: linshenpku@163.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100142
- Beijing Cancer Hospital
-
Contact:
- Lin Shen, Doctor of Medicine
- Phone Number: +86 13911219511
- Email: linshenpku@163.com
-
Beijing, Beijing, China, 100050
- Beijing Friendship Hospital, Capital Medical University
-
Contact:
- Zhongtao Zhang, Doctor
- Phone Number: +86 13801060364
- Email: zhangzht@ccmu.edu.cn
-
-
Gansu
-
Lanzhou, Gansu, China, 730030
- Lanzhou University Second Hospital
-
Contact:
- Wence Zhou, Doctor
- Phone Number: +86 13893699909
- Email: Zhouwc129@163.com
-
-
Hebei
-
Tangshan, Hebei, China, 063001
- Tangshan People's Hospital
-
Contact:
- Zhiwu Wang, Doctor
- Phone Number: +86 18931506162
- Email: tcm2000@163.com
-
-
Shanghai
-
Shanghai, Shanghai, China, 200433
- Third Affiliated Hospital of Naval Medical University
-
Contact:
- Feng Shen, Doctor of Medicine
- Phone Number: +86 13901651428
- Email: shenfengehbh@sina.com
-
-
Tianjin
-
Tianjin, Tianjin, China, 300181
- Tianjin Medical University Cancer Institute & Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- age ≥18 years old, ≤75 years old (calculated on the date of signing the informed consent); Eastern Cooperative oncology Group (ECOG) score 0 ~ 2.
- Tumor tissue samples must be provided for genetic testing (10 puncture paraffin sections or 5 surgical paraffin sections).
- Patients with viral hepatitis: Patients should be treated symptomatically until the virus is stable before enrollment, and treatment should be maintained during the experimental period.
- The main organs have good functions.
Meet the criteria for advanced biliary carcinoma:
- 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.
- Women of reproductive age should agree that they must use effective contraception during the study period and for 6 months after the study, and that serum or urine pregnancy tests are negative within 7 days prior to study enrollment; Men should agree that effective birth control must be used during the study period and for six months after the end of the study period.
- The subjects voluntarily joined the study, signed the informed consent, and the compliance was good.
Exclusion Criteria:
Complicated diseases and medical history.
- 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;
- Those who plan to undergo or have previously received allogeneic bone marrow transplantation or solid organ transplantation;
- A history of hepatic encephalopathy;
- Current or recent use (within 7 days prior to the start of study treatment) of aspirin (>325 mg/ day (maximum antiplatelet dose) or dipyridamole, ticlopidine, clopidogrel, and cilostazol;
Subjects with any severe and/or uncontrolled medical conditions, including:
- Poor blood pressure control (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg);
- have grade 2 myocardial ischemia or myocardial infarction, arrhythmias (including Corrected Q-T interval (QTC) ≥ 450ms in men and 470ms in women), and grade 2 congestive heart failure (New York Heart Association (NYHA) rating);
- Active or uncontrolled severe infection (≥CTCAE grade 2 infection);
- Patients with renal failure requiring hemodialysis or peritoneal dialysis;
- A history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases;
- People who have epilepsy and need treatment.
Tumor related and treatment:
- Hepatocellular carcinoma, fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, etc. confirmed by histology or cytology;
- According to imaging examination, cancer thrombus of the portal vein involved both the main trunk and the left and right primary branches, or involved both the main trunk and above veins (superior mesenteric vein, inferior mesenteric vein, spleen vein), or had cancer thrombus of the inferior vena cava or involved the heart;
- Uncontrolled pleural effusion, pericardial effusion or moderate to severe ascites that still require repeated drainage (the investigator's judgment);
- Known spinal cord compression, cancerous meningitis, symptoms of brain metastases, or symptoms controlled for less than 4 weeks.
Research and treatment related:
- Known allergy to study drug excipients.
- Patients with multiple factors affecting oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);
- Patients who require immunosuppressive, systemic, or absorbable topical hormone therapy for immunosuppressive purposes and who continue to use it within 7 days prior to initial administration (except for those whose daily dose of corticosteroids is less than 10 mg prednisone or other therapeutic hormones).
- Patients who participated in and used other antitumor clinical trials within 4 weeks before the first drug administration;
- According to the judgment of the researcher, there is any situation that seriously endangers the safety of the subject or affects the completion of the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TQB3454 tablets
TQB3454 tablets orally administered, 21 days as a treatment cycle.
|
TQB3454 is a selective IDH1 mutant enzyme inhibitor.
|
Placebo Comparator: Placebo
Placebo tablets orally administered, 21 days as a treatment cycle.
|
Placebo tablets without active substance.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival (OS)
Time Frame: Up to 18 months.
|
It refers to the time from randomization to the death from any cause.
|
Up to 18 months.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-Free-Survival (PFS)
Time Frame: Up to 12 months.
|
It refers to the time from randomization to disease progression or death, whichever occurs first.
|
Up to 12 months.
|
Progression-Free-Survival 2 (PFS2)
Time Frame: Up to 3 months.
|
The time between the first disease progression and the second disease progression or death, whichever comes first.
|
Up to 3 months.
|
Objective Response Rate (ORR)
Time Frame: Up to 18 months.
|
The percentage of subjects with complete response (CR) or partial response (PR).
|
Up to 18 months.
|
Disease Control Rate (DCR)
Time Frame: Up to 18 months.
|
The percentage of subjects with complete response (CR), partial response (PR) and stable disease (SD).
|
Up to 18 months.
|
Duration of response (DOR)
Time Frame: Up to 7 months.
|
The time from randomization to initiation of a new antitumor therapy or early termination of therapy.
|
Up to 7 months.
|
The European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30)
Time Frame: Up to 18 months.
|
It is an integrated system to describe the quality of life of cancer patients.
|
Up to 18 months.
|
The European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-BIL21)
Time Frame: Up to 18 months.
|
It is an integrated system to describe the quality of life of cancer patients.
|
Up to 18 months.
|
Incidence of adverse events (AE)
Time Frame: Up to 20 months.
|
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)
|
Up to 20 months.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
October 1, 2023
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Study Registration Dates
First Submitted
August 4, 2023
First Submitted That Met QC Criteria
August 4, 2023
First Posted (Actual)
August 14, 2023
Study Record Updates
Last Update Posted (Actual)
August 14, 2023
Last Update Submitted That Met QC Criteria
August 4, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TQB3454-III-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Biliary Carcinoma
-
Brno University HospitalRecruitingBiliary Tract Carcinoma | Biliary ObstructionCzechia
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Not yet recruiting
-
The First Affiliated Hospital with Nanjing Medical...Recruiting
-
University Health Network, TorontoWithdrawnGallbladder Carcinoma | Biliary Tract Carcinoma
-
University Health Network, TorontoActive, not recruitingGallbladder Carcinoma | Biliary Tract CarcinomaCanada
-
Fudan UniversityRecruitingBiliary Tract CarcinomaChina
-
Fudan UniversityActive, not recruitingBiliary Tract Carcinoma | Initially UnresectableChina
-
Hellenic Cooperative Oncology GroupGlaxoSmithKlineTerminatedCholangiocarcinoma | Gallbladder Carcinoma | Biliary CarcinomaGreece
-
AstraZenecaRecruitingHepatocellular Carcinoma | Biliary Tract CancerChina, Spain, Korea, Republic of, Italy, United Kingdom, United States, Japan, Taiwan, Hong Kong
-
Krankenhaus NordwestGerman Research FoundationRecruitingBiliary Tract Cancer | Incidental Gallbladder CarcinomaGermany
Clinical Trials on TQB3454 tablets
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.RecruitingAcute Myeloid Leukemia | Myelodysplastic SyndromesChina
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Not yet recruiting
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.RecruitingAdvanced Solid Tumor or Hematologic TumorChina
-
Centre of Clinical Pharmacology, Hanoi Medical...Not yet recruitingIrritable Bowel Syndrome With DiarrheaVietnam
-
Cara Therapeutics, Inc.RecruitingPruritus | Notalgia ParestheticaUnited States, Poland, Spain, Canada, Germany
-
Jiangsu vcare pharmaceutical technology co., LTDCompletedInflammatory Bowel DiseasesChina
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Not yet recruiting
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Not yet recruitingHematologic MalignancyChina
-
Jiangsu HengRui Medicine Co., Ltd.Completed