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 @ 7:32 PM
Ignite Modification Date:
2025-12-24 @ 7:32 PM
NCT ID:
NCT02146703
Eligibility Criteria:
Inclusion Criteria:
* Unresectable, locally advanced, metastatic adenocarcinoma arising from the intra- and extrahepatic biliary ducts or gallbladder
* Initially diagnosed or recurred
* At least one bidimensionally measurable lesion, defined as at least 1x1cm with clearly defined margins on physical examination, on 3-dimentional CT, MRI, or PET-CT
* Age ≥18 and ≤70 years
* Estimated life expectancy ≥3 months
* ECOG performance status ≤2
* Adequate bone marrow function (WBCs ≥4,000/µL or absolute neutrophil count ≥1,500/µL, platelets ≥100,000/µL),
* Adequate kidney function (creatinine ≤1.4 mg/dL)
* Adequate liver function (bilirubin ≤1.8 mg/dL, transaminase levels ≤100mg/dL)
* Written informed consent
Exclusion Criteria:
* Other tumor type than adenocarcinoma
* Previous history of chemotherapy (exception : adjuvant chemotherapy)
* Presence of CNS metastasis, psychosis, or seizure
* Obvious bowel obstruction
* Evidence of serious gastrointestinal bleeding
* Past or concurrent history of neoplasm other than biliary adenocarcinoma, except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix uteri
* Pregnant or lactating women, women of childbearing potential not employing adequate contraception
* Other serious illness or medical conditions
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02146703
Study Brief:
Protocol Section:
NCT02146703