Trial Title:
A Clinical Study of TQB3454 Tablets in the Treatment of Advanced Biliary Carcinoma.
NCT ID:
NCT05987358
Condition:
Biliary Carcinoma
Conditions: Official terms:
Carcinoma
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
TQB3454 tablets
Description:
TQB3454 is a selective IDH1 mutant enzyme inhibitor.
Arm group label:
TQB3454 tablets
Intervention type:
Drug
Intervention name:
TQB3454 tablets matching placebo
Description:
Placebo tablets without active substance.
Arm group label:
Placebo
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.
Criteria for eligibility:
Criteria:
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:
1. cholangiocarcinoma histologically or cytologically confirmed
2. 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.
3. 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.
1. The patient had or was currently present with other malignant tumors within 3
years prior to the first medication.
2. Unmitigated toxic reactions above class 1 of Common Terminology Criteria for
Adverse Events V5.0 (CTCAE) due to any previous treatment, excluding hair loss;
3. Received major surgical treatment, significant traumatic injury, or
long-standing unhealed wounds or fractures within 4 weeks prior to initial
medication;
4. 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;
5. 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;
6. Those who have the history of psychotropic drug abuse and cannot abstain or
have mental disorders;
7. Those who plan to undergo or have previously received allogeneic bone marrow
transplantation or solid organ transplantation;
8. A history of hepatic encephalopathy;
9. 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;
10. Subjects with any severe and/or uncontrolled medical conditions, including:
1. Poor blood pressure control (systolic blood pressure ≥150 mmHg or
diastolic blood pressure ≥100 mmHg);
2. 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);
3. Active or uncontrolled severe infection (≥CTCAE grade 2 infection);
4. Patients with renal failure requiring hemodialysis or peritoneal dialysis;
5. A history of immunodeficiency, including HIV positive or other acquired or
congenital immunodeficiency diseases;
6. People who have epilepsy and need treatment.
- Tumor related and treatment:
1. Hepatocellular carcinoma, fibrolamellar hepatocellular carcinoma, sarcomatoid
hepatocellular carcinoma, etc. confirmed by histology or cytology;
2. 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;
3. Uncontrolled pleural effusion, pericardial effusion or moderate to severe
ascites that still require repeated drainage (the investigator's judgment);
4. Known spinal cord compression, cancerous meningitis, symptoms of brain
metastases, or symptoms controlled for less than 4 weeks.
- Research and treatment related:
1. Known allergy to study drug excipients.
2. Patients with multiple factors affecting oral medication (such as inability to
swallow, chronic diarrhea and intestinal obstruction);
3. 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Friendship Hospital, Capital Medical University
Address:
City:
Beijing
Zip:
100050
Country:
China
Contact:
Last name:
Zhongtao Zhang, Doctor
Phone:
+86 13801060364
Email:
zhangzht@ccmu.edu.cn
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Zip:
100142
Country:
China
Contact:
Last name:
Lin Shen, Doctor of Medicine
Phone:
+86 13911219511
Email:
linshenpku@163.com
Facility:
Name:
Lanzhou University Second Hospital
Address:
City:
Lanzhou
Zip:
730030
Country:
China
Contact:
Last name:
Wence Zhou, Doctor
Phone:
+86 13893699909
Email:
Zhouwc129@163.com
Facility:
Name:
Tangshan People's Hospital
Address:
City:
Tangshan
Zip:
063001
Country:
China
Contact:
Last name:
Zhiwu Wang, Doctor
Phone:
+86 18931506162
Email:
tcm2000@163.com
Facility:
Name:
Third Affiliated Hospital of Naval Medical University
Address:
City:
Shanghai
Zip:
200433
Country:
China
Contact:
Last name:
Feng Shen, Doctor of Medicine
Phone:
+86 13901651428
Email:
shenfengehbh@sina.com
Facility:
Name:
Tianjin Medical University Cancer Institute & Hospital
Address:
City:
Tianjin
Zip:
300181
Country:
China
Start date:
October 2023
Completion date:
December 2026
Lead sponsor:
Agency:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Agency class:
Industry
Source:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05987358
