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

NCT07729917 | Not Yet Recruiting Phase 2

• 1 other identifier: CAPT07
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Bile Duct Carcinoma; Cholangiocarcinoma

Outcome Measures

Primary Outcomes (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.

  From enrollment to upto 2 years

Secondary Outcomes (3)

• Progression-Free Survival (PFS)

  From enrollment to upto 2 years

• Overall Survival (OS)

  From enrollment to upto 3 years

• Disease Control Rate (DCR)

  From enrollment to upto 2 years

Study Arms (8)

Arm A

EXPERIMENTAL

patients with FGFR mutation. FGFR mutation inhibitor with GP/GEMOX.

Drug: FGFR Inhibitor; Device: Chemotherapy: GP/GEMOX

Arm B

EXPERIMENTAL

patients with IDH1 mutation. IDH1 mutation inhibitor with GP/GEMOX

Drug: IDH1 mutation inhibitor; Device: Chemotherapy: GP/GEMOX

Arm C

EXPERIMENTAL

Patients with KRAS mutation. KRAS mutation inhibitor with GP/GEMOX

Drug: KRAS mutation inhibitor; Device: Chemotherapy: GP/GEMOX

Arm D

EXPERIMENTAL

Patients with NTRK mutation. NTRK mutation inhibitor with GP/GEMOX.

Drug: NTRK mutation inhibitor; Device: Chemotherapy: GP/GEMOX

Arm E

EXPERIMENTAL

Patients with BRAF V600E mutation. BRAF V600E mutation inhibitor with GP/GEMOX.

Drug: BRAF V600E mutation inhibitor; Device: Chemotherapy: GP/GEMOX

Arm F

EXPERIMENTAL

Patients with BRCA 1/2 mutation. BRCA 1/2 mutation inhibitor with GP/GEMOX.

Drug: BRCA 1/2 mutation inhibitor; Device: Chemotherapy: GP/GEMOX

Arm G

EXPERIMENTAL

Patients with HER2 positive. Trastuzumab rezetecan with GP/GEMOX.

Drug: HER2 target therapy; Device: Chemotherapy: GP/GEMOX

Arm H

EXPERIMENTAL

Patients without any known target. ICI with GP/GEMOX.

Drug: Immune Checkpoint Inhibitors; Device: Chemotherapy: GP/GEMOX

Interventions

FGFR Inhibitor DRUG

FGFR Inhibitor

Arm A

IDH1 mutation inhibitor DRUG

IDH1 mutation inhibitor

Arm B

KRAS mutation inhibitor DRUG

KRAS mutation inhibitor

Arm C

NTRK mutation inhibitor DRUG

NTRK mutation inhibitor

Arm D

BRAF V600E mutation inhibitor DRUG

BRAF V600E mutation inhibitor

Arm E

BRCA 1/2 mutation inhibitor DRUG

BRCA 1/2 mutation inhibitor

Arm F

HER2 target therapy DRUG

HER2 target therapy

Arm G

Immune Checkpoint Inhibitors DRUG

Immune Checkpoint Inhibitors

Arm H

Chemotherapy: GP/GEMOX DEVICE

Chemotherapy: GP/GEMOX

Arm A; Arm B; Arm C; Arm D; Arm E; Arm F; Arm G; Arm H

Eligibility Criteria

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

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Zhejiang University: lead

Study Sites (1)

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Bile Duct Neoplasms; Cholangiocarcinoma

Interventions

Immune Checkpoint Inhibitors

Condition Hierarchy (Ancestors)

Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Central Study Contacts

Tingbo Liang, MD

CONTACT

86+19941463683; liangtingbo@zju.edu.cn

Yiwen Chen, MD

CONTACT

86+15088682641; yiwenchen0705@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The chairman of the First Affiliated Hospital of Zhejiang University School of Medicine

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: July 28, 2026
• Study Start (Estimated): August 10, 2026
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)