Clinical trial · Interventional
Precision Integrated Strategies and Efficacy Evaluation for Biliary Tract Cancers: An Umbrella Platform Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bile Duct Carcinoma | Cholangiocarcinoma | ALIAS | 0.90 |
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BRAF V600E mutation inhibitor | Drug | — | UNRESOLVED |
| BRCA 1/2 mutation inhibitor | Drug | — | UNRESOLVED |
| Chemotherapy: GP/GEMOX | Device | — | UNRESOLVED |
| FGFR Inhibitor | Drug | — | UNRESOLVED |
| HER2 target therapy | Drug | — | UNRESOLVED |
| IDH1 mutation inhibitor | Drug | — | UNRESOLVED |
| Immune Checkpoint Inhibitors | Drug | — | UNRESOLVED |
| KRAS mutation inhibitor | Drug | — | UNRESOLVED |
| NTRK mutation inhibitor |
Design
Arms and outcomes
Arms (8)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- patients with FGFR mutation. FGFR mutation inhibitor with GP/GEMOX.
- interventionNames
- Drug: FGFR Inhibitor
- Device: Chemotherapy: GP/GEMOX
- type
- EXPERIMENTAL
- label
- Arm B
- description
- patients with IDH1 mutation. IDH1 mutation inhibitor with GP/GEMOX
- interventionNames
- Drug: IDH1 mutation inhibitor
- Device: Chemotherapy: GP/GEMOX
- type
- EXPERIMENTAL
- label
- Arm C
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available