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:
2025-12-24 @ 3:03 PM
Ignite Modification Date:
2025-12-24 @ 3:03 PM
NCT ID:
NCT05532059
Eligibility Criteria:
Inclusion Criteria:
* Histologically proven, unresectable advanced or metastatic cholangiocarcinoma patients.
* the world health organization (WHO)/ECOG physical state (PS) to 0 or 1.
* at least 1 RECIST 1.1 standard target lesions.
* not previously received immunotherapy, including but not limited to CTLA 4, PD-L1 or/and PD-1 inhibitors.
* adequate organ and bone marrow function, defined as follows: 9.0 g/dL or higher hemoglobin; neutrophil count 1.5 x 109 / L; platelet count 100 x 109 / L.
Exclusion Criteria:
* Active or previously documented autoimmune disease or inflammatory disease.
* Uncontrolled complications.
* History of other primary malignancies.
* Active infection.
* Women who are pregnant or breastfeeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT05532059
Study Brief:
Protocol Section:
NCT05532059