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 @ 3:51 PM
Ignite Modification Date:
2025-12-24 @ 3:51 PM
NCT ID:
NCT01219192
Eligibility Criteria:
Inclusion Criteria:
1. histologically or cytologically confirmed pancreatic adenocarcinoma that was not amenable to potentially curative surgery.
2. All patients must have developed progressive disease (PD) while receiving or within 6 months after discontinuing palliative gemcitabine-based chemotherapy
3. Prior radiation therapy was allowed provided that the only sites of measurable disease were not located within the radiation port.
4. 18 years of age or older
5. Karnofsky performance status (KPS) of 60-100 points
6. measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
7. Adequate hematologic, renal, and hepatic function was required as deWned by the following: WBC ≥3.5×109/L, absolute neutrophil count ≥ 1.5 × 109/L, platelet count ≥100 × 109/L, hemoglobin≥9g/dL, total bilirubin ≤2.5 upper limit of normal \[ULN\],AST≤2.5 ULN, or≤5 ULN if there was evidence of liver metastases;alkaline phosphatase≤ 2.5 ULN, or≤ 5 ULN if there was evidence of liver Metastases creatinine clearance≤50 mL/min,
8. life expectancy of at least 12 weeks
Exclusion Criteria:
1. patients had clinically apparent CNS metastases or carcinomatous meningitis
2. another active malignancy, or any history of other malignancy within the past 5 years except for nonmelanoma skin cancer and carcinoma in situ of the cervix
3. more than 3 weeks intervals between the last administration of the prior chemotherapy regimen and study entry
4. more than 4 weeks intervals between the last administration of the targeted therapy regimen and study entry
5. major surgery within the prior 6 weeks;
6. Pregnant or lactating women
7. tumor involvement of major blood vessels
8. uncontrolled intercurrent illness
9. A history of myocardial infarction or stroke within the last 6 months, uncontrolled hypertension, unstable angina
10. clinically significant cardiac disease (eg, congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication, or myocardial infarction)
11. urine protein ≥ 500 mg in 24 hours;
12. evidence of bleeding diathesis or coagulopathy
13. Patients on therapeutic doses of low-molecular weight heparin
14. Patients who received thrombolytic agents within the previous month or who required full-dose anticoagulation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01219192
Study Brief:
Protocol Section:
NCT01219192