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

Starting soon · Phase 2

Conditions studied: Bile Duct Carcinoma, Cholangiocarcinoma

In brief

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 facts

Study ID: NCT07729917
Run by: Zhejiang University
People needed: 240
Starts: 2026-08-10
Expected to finish: 2030-12-31
Last updated by the study team: 2026-07-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.
Other patients deemed unsuitable for inclusion by the treating physician.

Where it is running

The First Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou, Zhejiang, China

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.