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:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07310069
Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent.
* Age 18-75 years.
* ECOG performance status 0-2, Child-Pugh class A.
* Histologically or cytologically confirmed advanced gallbladder cancer, deemed unresectable for R0 resection.
* Adequate organ function:
* ANC ≥1.5×10⁹/L, platelets ≥75×10⁹/L, hemoglobin ≥90 g/L.
* Serum creatinine ≤1.2 mg/dL or creatinine clearance ≥60 mL/min.
* Total bilirubin ≤1.5×ULN (≤3×ULN if liver metastases); AST/ALT ≤3×ULN (≤5×ULN if liver metastases).
* Life expectancy ≥3 months.
* Non-pregnant, non-lactating women and willingness to use contraception during and for 3 months after treatment.
Exclusion Criteria:
* Severe systemic infection or uncontrolled comorbidities (e.g., heart failure, thyroid disease, psychiatric disorders); active autoimmune disease requiring medication.
* Known allergy or intolerance to chemotherapy agents.
* Prior antitumor therapy (chemotherapy, radiotherapy, immunotherapy) within the past year, or history of other malignancies (except cured cervical carcinoma in situ or non-melanoma skin cancer).
* Pregnancy, lactation, or unwillingness to use contraception.
* Participation in another clinical trial within 30 days before the first dose.
* Unwillingness to participate or inability to provide informed consent.
* Any other condition that, in the investigator's judgment, may affect patient safety or compliance
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07310069
Study Brief:
Protocol Section:
NCT07310069