Precision Integrated Strategies and Efficacy Evaluation for Biliary Tract Cancers: An Umbrella Platform Study
NCT07729917 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 240
Last updated 2026-07-28
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
Interventions
- DRUG
-
BRCA 1/2 mutation inhibitor
BRCA 1/2 mutation inhibitor
- DRUG
-
HER2 target therapy
HER2 target therapy
- DRUG
-
Immune Checkpoint Inhibitors
Immune Checkpoint Inhibitors
- DEVICE
-
Chemotherapy: GP/GEMOX
Chemotherapy: GP/GEMOX
- DRUG
-
FGFR Inhibitor
FGFR Inhibitor
- DRUG
-
IDH1 mutation inhibitor
IDH1 mutation inhibitor
- DRUG
-
KRAS mutation inhibitor
KRAS mutation inhibitor
- DRUG
-
NTRK mutation inhibitor
NTRK mutation inhibitor
- DRUG
-
BRAF V600E mutation inhibitor
BRAF V600E mutation inhibitor
Sponsors & Collaborators
-
Zhejiang University
lead OTHER
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-08-10
- Primary Completion
- 2028-08-31
- Completion
- 2030-12-31
Countries
- China
Study Locations
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