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Biliary CarcinomaPhase 3NCT05987358

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

A Phase 3 study testing TQB3454 tablets in people with Biliary Carcinoma, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 6 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Biliary Carcinoma
What is being tested?
TQB3454 tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
165 participants
Where
6 sitesChina
Study dates
21 Sep 2023to Dec 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

China6 sites

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100050

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

  • Lanzhou University Second Hospital

    Lanzhou, Gansu, 730030

  • Third Affiliated Hospital of Naval Medical University

    Shanghai, Shanghai Municipality, 200433

  • Tangshan People's Hospital

    Tangshan, Hebei, 063001

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality, 300181

Other trials in China

About this study

Official title: 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.

Being tested
TQB3454 tablets, TQB3454 tablets matching placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TQB3454 tabletsDrug

    TQB3454 is a selective IDH1 mutant enzyme inhibitor.

  • TQB3454 tablets matching placeboDrug

    Placebo tablets without active substance.

Study groups in NCT05987358
Study groupRoleWhat they receive
TQB3454 tabletsExperimentalTQB3454 tablets orally administered, 21 days as a treatment cycle.
Receives: Drug: TQB3454 tablets
PlaceboPlacebo comparatorPlacebo tablets orally administered, 21 days as a treatment cycle.
Receives: Drug: TQB3454 tablets matching placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival (OS)

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

    Measured: Up to 18 months.

Secondary outcomes (8)

  1. Progression-Free-Survival (PFS)

    It refers to the time from randomization to disease progression or death, whichever occurs first.

    Measured: Up to 12 months.

  2. Progression-Free-Survival 2 (PFS2)

    The time between the first disease progression and the second disease progression or death, whichever comes first.

    Measured: Up to 3 months.

  3. Objective Response Rate (ORR)

    The percentage of subjects with complete response (CR) or partial response (PR).

    Measured: Up to 18 months.

  4. Disease Control Rate (DCR)

    The percentage of subjects with complete response (CR), partial response (PR) and stable disease (SD).

    Measured: Up to 18 months.

  5. Duration of response (DOR)

    The time from randomization to initiation of a new antitumor therapy or early termination of therapy.

    Measured: Up to 7 months.

  6. The European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30)

    It is an integrated system to describe the quality of life of cancer patients.

    Measured: Up to 18 months.

  7. The European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-BIL21)

    It is an integrated system to describe the quality of life of cancer patients.

    Measured: Up to 18 months.

  8. Incidence of adverse events (AE)

    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)

    Measured: Up to 20 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2023
  2. Study start21 Sep 2023
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
165 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05987358
Sponsor's protocol ID
TQB3454-III-01
Status last verified
Aug 2025
First submitted
4 Aug 2023
Last updated
11 Mar 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TQB3454 tablets in people with Biliary Carcinoma, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 6 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (OS) (time frame: Up to 18 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05987358.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.

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