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Starting soon Phase 2

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

NCT07729917 · tracked via the Priya Life Science China tracker
Phase
Phase 2
Started
2026-08-10
Last updated
2026-07-28

Condition(s) studied

Bile Duct CarcinomaCholangiocarcinoma

Investigational drug(s) / intervention(s)

FGFR InhibitorIDH1 mutation inhibitorKRAS mutation inhibitorNTRK mutation inhibitorBRAF V600E mutation inhibitorBRCA 1/2 mutation inhibitorHER2 target therapyImmune Checkpoint InhibitorsChemotherapy: GP/GEMOX

FGFR Inhibitor: FGFR Inhibitor

IDH1 mutation inhibitor: IDH1 mutation inhibitor

KRAS mutation inhibitor: KRAS mutation inhibitor

NTRK mutation inhibitor: NTRK mutation inhibitor

BRAF V600E mutation inhibitor: BRAF V600E mutation inhibitor

BRCA 1/2 mutation inhibitor: BRCA 1/2 mutation inhibitor

HER2 target therapy: HER2 target therapy

Immune Checkpoint Inhibitors: Immune Checkpoint Inhibitors

Chemotherapy: GP/GEMOX: Chemotherapy: GP/GEMOX

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * Other patients deemed unsuitable for inclusion by the treating physician.

Primary outcome measure(s)

  • Objective Response Rate (ORR) — From enrollment to upto 2 years
    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.

Trial sites (1)

FacilityCityRegionStatus
The First Affiliated Hospital of Zhejiang University School of Medicine Hangzhou Zhejiang
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07729917 on ClinicalTrials.gov ↗ ← All trials in China