A Clinical Study of TQB3454 Tablets in the Treatment of Advanced Biliary Carcinoma.

NCT05987358 | Active Not Recruiting Phase 3

• 1 other identifier: TQB3454-III-01
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Biliary Carcinoma

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

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

  Up to 18 months.

Secondary Outcomes (8)

• Progression-Free-Survival (PFS)

  Up to 12 months.

• Progression-Free-Survival 2 (PFS2)

  Up to 3 months.

• Objective Response Rate (ORR)

  Up to 18 months.

• Disease Control Rate (DCR)

  Up to 18 months.

• Duration of response (DOR)

  Up to 7 months.

Study Arms (2)

TQB3454 tablets

EXPERIMENTAL

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

Drug: TQB3454 tablets

Placebo

PLACEBO COMPARATOR

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

Drug: TQB3454 tablets matching placebo

Interventions

TQB3454 tablets DRUG

TQB3454 is a selective IDH1 mutant enzyme inhibitor.

TQB3454 tablets

TQB3454 tablets matching placebo DRUG

Placebo tablets without active substance.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (6)

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

Location

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Lanzhou University Second Hospital

Lanzhou, Gansu, 730030, China

Location

Tangshan People's Hospital

Tangshan, Hebei, 063001, China

Location

Third Affiliated Hospital of Naval Medical University

Shanghai, Shanghai Municipality, 200433, China

Location

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, 300181, China

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2023
• First Posted: August 14, 2023
• Study Start: September 21, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 11, 2026

Record last verified: 2025-08

Locations

CN (6)