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Bile Duct CarcinomaPhase 2NCT07729917

Precision Integrated Strategies and Efficacy Evaluation for Biliary Tract Cancers: An Umbrella Platform Study

A Phase 2 study testing FGFR Inhibitor, IDH1 mutation inhibitor and KRAS mutation inhibitor in people with Bile Duct Carcinoma and Cholangiocarcinoma, run by Zhejiang University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study is a prospective, multicenter, open-label, umbrella phase II clinical trial. Based on different multigene expression profiling subtypes and potential molecular characteristics of various pathways, 8 treatment arms and 13 treatment groups are preliminarily designed. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bile Duct Carcinoma, Cholangiocarcinoma
What is being tested?
FGFR Inhibitor, IDH1 mutation inhibitor and KRAS mutation inhibitor
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
1 siteChina
Study dates
10 Aug 2026to 31 Dec 2030
Phase
Phase 2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patient voluntarily joins this study and signs the informed consent form.
  • Age: ≥18 years, male or female.
  • Histologically or cytologically confirmed advanced biliary tract malignancies, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer.
  • No prior systemic therapy for advanced BTC (biliary tract cancer).
  • At least one measurable lesion as per RECIST v1.1 (spiral CT scan long diameter ≥10 mm or short diameter of enlarged lymph node ≥15 mm; lesions previously treated with local therapy may be considered target lesions only after documented progression according to RECIST v1.1).
  • ECOG performance status: 0-1.
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  • Expected survival ≥12 weeks.
  • Adequate major organ function.
  • Female subjects of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days before the first dose, must not be breastfeeding, and must voluntarily agree to use effective contraceptive measures during the study period and for 6 months after the last dose of chemotherapy. For male subjects with a female partner of childbearing potential, they must be surgically sterile or agree to use effective contraceptive measures during the study period and for 3 months after the last dose of chemotherapy; sperm donation is not allowed during the study.
  • Subjects are expected to have good compliance and be able to follow the protocol requirements for efficacy and adverse event follow-up.

Who cannot join

  • Has another active malignancy other than BTC within 5 years or concurrently.
  • Has poorly controlled cardiac clinical symptoms or diseases.
  • Has hypertension that cannot be reduced to normal range with antihypertensive medication; has a history of hypertensive crisis or hypertensive encephalopathy.
  • Any clinically significant gastrointestinal disorders, including bleeding, inflammation, obstruction, or diarrhea > grade 2.
  • Has experienced thrombotic or embolic events within 6 months before the start of study treatment.
  • Use of strong CYP3A4/CYP2C19 inducers (including rifampin and its analogues, and St. John's Wort) or strong CYP3A4/CYP2C19 inhibitors and/or strong UGT1A inhibitors within 14 days prior to signing the informed consent form.
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  • Has uncontrolled infection at screening.
  • Patients with congenital or acquired immunodeficiency.
  • Has a history of brain metastases or has brain metastases.
  • Women who are pregnant or plan to become pregnant during the study treatment period.
  • Other patients deemed unsuitable for inclusion by the treating physician.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Tingbo Liang, MD contact

86+19941463683

liangtingbo@zju.edu.cn

Yiwen Chen, MD contact

86+15088682641

yiwenchen0705@126.com

China1 site

  • The First Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310000

    Yiwen Chen, 86+19941463683, yiwenchen0705@126.com

Other trials in China

About this study

This study is a prospective, multicenter, open-label, umbrella phase II clinical trial. Based on different multigene expression profiling subtypes and potential molecular characteristics of various pathways, 8 treatment arms and 13 treatment groups are preliminarily designed. After successful screening, investigators will assign eligible subjects to a treatment group based on the patient's genetic test report (if available) and performance status. For subjects without a genetic test report, they will be allocated to Arm H to receive immunotherapy combined with chemotherapy or other regimens.

Read the detailed description

This study is a prospective, multicenter, open-label, umbrella phase II clinical trial. Based on different multigene expression profiling subtypes and potential molecular characteristics of various pathways, 8 treatment arms and 13 treatment groups are preliminarily designed. After successful screening, investigators will assign eligible subjects to a treatment group based on the patient's genetic test report (if available) and performance status. For subjects without a genetic test report, they will be allocated to Arm H to receive immunotherapy combined with chemotherapy or other regimens. The mutations involved include the following: A: FGFR, B: IDH1, C: KRAS, D: NTRK, E: BRAF V600E, F: BRCA1/2, G: HER2, and H: pan-negative. Additional corresponding targets may be added later based on clinical practice.

Being tested
FGFR Inhibitor, IDH1 mutation inhibitor, KRAS mutation inhibitor, NTRK mutation inhibitor, BRAF V600E mutation inhibitor
Medical subject headings
Bile Duct Neoplasms, Cholangiocarcinoma

What participants receive

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

  • FGFR InhibitorDrug

    FGFR Inhibitor

  • IDH1 mutation inhibitorDrug

    IDH1 mutation inhibitor

  • KRAS mutation inhibitorDrug

    KRAS mutation inhibitor

  • NTRK mutation inhibitorDrug

    NTRK mutation inhibitor

  • BRAF V600E mutation inhibitorDrug

    BRAF V600E mutation inhibitor

  • BRCA 1/2 mutation inhibitorDrug

    BRCA 1/2 mutation inhibitor

  • HER2 target therapyDrug

    HER2 target therapy

  • Immune Checkpoint InhibitorsDrug

    Immune Checkpoint Inhibitors

  • Chemotherapy: GP/GEMOXDevice

    Chemotherapy: GP/GEMOX

Study groups in NCT07729917
Study groupRoleWhat they receive
Arm AExperimentalpatients with FGFR mutation. FGFR mutation inhibitor with GP/GEMOX.
Receives: Drug: FGFR Inhibitor; Device: Chemotherapy: GP/GEMOX
Arm BExperimentalpatients with IDH1 mutation. IDH1 mutation inhibitor with GP/GEMOX
Receives: Drug: IDH1 mutation inhibitor; Device: Chemotherapy: GP/GEMOX
Arm CExperimentalPatients with KRAS mutation. KRAS mutation inhibitor with GP/GEMOX
Receives: Drug: KRAS mutation inhibitor; Device: Chemotherapy: GP/GEMOX
Arm DExperimentalPatients with NTRK mutation. NTRK mutation inhibitor with GP/GEMOX.
Receives: Drug: NTRK mutation inhibitor; Device: Chemotherapy: GP/GEMOX
Arm EExperimentalPatients with BRAF V600E mutation. BRAF V600E mutation inhibitor with GP/GEMOX.
Receives: Drug: BRAF V600E mutation inhibitor; Device: Chemotherapy: GP/GEMOX
Arm FExperimentalPatients with BRCA 1/2 mutation. BRCA 1/2 mutation inhibitor with GP/GEMOX.
Receives: Drug: BRCA 1/2 mutation inhibitor; Device: Chemotherapy: GP/GEMOX
Arm GExperimentalPatients with HER2 positive. Trastuzumab rezetecan with GP/GEMOX.
Receives: Drug: HER2 target therapy; Device: Chemotherapy: GP/GEMOX
Arm HExperimentalPatients without any known target. ICI with GP/GEMOX.
Receives: Drug: Immune Checkpoint Inhibitors; Device: Chemotherapy: GP/GEMOX

What is being measured

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

  1. Objective Response Rate (ORR)

    Objective Response Rate (ORR), defined as the proportion of subjects in the analysis population who have a confirmed complete response (CR) or partial response (PR) according to RECIST version 1.1.

    Measured: From enrollment to upto 2 years

Secondary outcomes (3)

  1. Progression-Free Survival (PFS)

    Progression-Free Survival (PFS), defined as the time from randomization to the first documented disease progression or death from any cause, whichever occurs first.

    Measured: From enrollment to upto 2 years

  2. Overall Survival (OS)

    Overall Survival (OS), defined as the time from randomization to death from any cause.

    Measured: From enrollment to upto 3 years

  3. Disease Control Rate (DCR)

    Disease Control Rate (DCR), defined as the percentage of patients with confirmed complete response, partial response, or stable disease (≥ 8 weeks) among efficacy-evaluable patients.

    Measured: From enrollment to upto 2 years

Timeline

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

  1. First posted28 Jul 2026
  2. Study start10 Aug 2026 (estimated)
  3. Primary completion31 Aug 2028 (estimated)
  4. Study completion31 Dec 2030 (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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07729917
Sponsor's protocol ID
CAPT07
Status last verified
Jul 2026
First submitted
20 Jul 2026
Last updated
28 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing FGFR Inhibitor, IDH1 mutation inhibitor and KRAS mutation inhibitor in people with Bile Duct Carcinoma and Cholangiocarcinoma, run by Zhejiang University at 1 site 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 11 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: opening soon, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Contact Tingbo Liang, MD (86+19941463683, liangtingbo@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: From enrollment to upto 2 years). 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 NCT07729917.

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 28 Jul 2026.

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