Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2025-12-25 @ 4:15 AM
NCT ID:
NCT06591520
Eligibility Criteria:
Inclusion Criteria:
* Be able and willing to provide written informed consent.
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Has a life expectancy of at least 3 months.
* Has a histologically or cytologically confirmed diagnosis of biliary tract cancer (BTC).
* Has no prior systemic anti-tumor therapy for unresectable locally advanced or metastatic BTC.
* Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
* Has adequate organ function.
Exclusion Criteria:
* Has other malignancies within 5 years prior to enrollment.
* Is currently participating in a study of an investigational agent or using an investigational device.
* Has known active central nervous system (CNS) metastases.
* Has an active autoimmune disease that has required systemic treatment in the past 2 years.
* Has an active infection requiring systemic therapy.
* Has known active Hepatitis B or Hepatitis C.
* History of myocardial infarction, unstable angina, congestive heart failure within 12 months prior to enrollment.
* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
* Has received a live virus vaccine within 30 days of the planned first dose of study therapy.
* Has any concurrent medical condition that, in the opinion of the Investigator, would complicate or compromise compliance with the study or the well-being of the subject.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06591520
Study Brief:
Protocol Section:
NCT06591520