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

Sponsor
Zhejiang University
Study ID
NCT07729917
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Bile Duct Carcinoma
  • Cholangiocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • FGFR Inhibitor — DRUG
    FGFR Inhibitor
  • IDH1 mutation inhibitor — DRUG
    IDH1 mutation inhibitor
  • KRAS mutation inhibitor — DRUG
    KRAS mutation inhibitor
  • NTRK mutation inhibitor — DRUG
    NTRK mutation inhibitor
  • BRAF V600E mutation inhibitor — DRUG
    BRAF V600E mutation inhibitor
  • BRCA 1/2 mutation inhibitor — DRUG
    BRCA 1/2 mutation inhibitor
  • HER2 target therapy — DRUG
    HER2 target therapy
  • Immune Checkpoint Inhibitors — DRUG
    Immune Checkpoint Inhibitors
  • Chemotherapy: GP/GEMOX — DEVICE
    Chemotherapy: GP/GEMOX

Study Details

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.

Key Dates

First listed
Jul 28, 2026
Start date
Aug 10, 2026
Status verified
Jul 2026
Primary completion
Aug 31, 2028
Completion
Dec 31, 2030

Study Design

Enrollment
240 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    patients with FGFR mutation. FGFR mutation inhibitor with GP/GEMOX.
  • Experimental: Arm B
    patients with IDH1 mutation. IDH1 mutation inhibitor with GP/GEMOX
  • Experimental: Arm C
    Patients with KRAS mutation. KRAS mutation inhibitor with GP/GEMOX
  • Experimental: Arm D
    Patients with NTRK mutation. NTRK mutation inhibitor with GP/GEMOX.
  • Experimental: Arm E
    Patients with BRAF V600E mutation. BRAF V600E mutation inhibitor with GP/GEMOX.
  • Experimental: Arm F
    Patients with BRCA 1/2 mutation. BRCA 1/2 mutation inhibitor with GP/GEMOX.
  • Experimental: Arm G
    Patients with HER2 positive. Trastuzumab rezetecan with GP/GEMOX.
  • Experimental: Arm H
    Patients without any known target. ICI with GP/GEMOX.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: From enrollment to upto 2 years ]

Central Contacts

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