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 @ 11:28 PM
Ignite Modification Date:
2025-12-24 @ 11:28 PM
NCT ID:
NCT02704156
Eligibility Criteria:
Inclusion Criteria:
1. Histologically confirmed pancreatic ductal adenocarcinoma with unequivocal first progression after surgery followed by chemotherapy
2. Without any immunotherapy or targeted therapy
3. A life expectancy of \>3months
4. ECOG of 0 to1
5. Age of 18 years or older
6. Analysis of surgical specimens showed KRAS mutations and positive immunohistochemical staining of PD-L1
7. Blood routine examination: Absolute neutrophil count (ANC) ≥ 1.5 ×109 cells/L, leukocyte count≥ 3.5 ×109 cells/L, platelets ≥ 70×109 cells/L, hemoglobin ≥ 8.0 g/dl
8. Liver and kidney function tests: Albumin \> 2.5 g/dL, total bilirubin \< 3 mg/dL, creatinine \< 2.0 mg/dL, AST\<2.5 × ULN(Upper Limit of Normal)(0-64U/L), ALT\<2.5 × ULN(0-64U/L)
9. INR \< 2 (0.9-1.1)
10. Ability of the research subject or authorized legal representative to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
1. Prior immunotherapy or targeted therapy
2. Evidences of metastatic disease confirmed by chest CT or FDG PET-CT
3. Contraindication to receiving immunotherapy, targeted therapy or SBRT
4. ECOG ≥2
5. Age \<18 years
6. Analysis of surgical specimens showed KRAS wild type or negative immunohistochemical staining of PD-L1
7. Secondary malignancy
8. Abnormal results of blood routine examinations and liver and kidney and coagulation tests
9. Patients with active inflammatory bowel diseases or peptic ulcer
10. Gastrointestinal bleeding or perforation within 6 months
11. Heart failure: NYHA III-IV
12. Respiratory insufficiency
13. Women who are pregnant
14. Participation in another clinical treatment trial while on study
15. Patients in whom fiducial implantation was not possible
16. Inability of the research subject or authorized legal representative to understand and the willingness to sign a written informed consent document.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02704156
Study Brief:
Protocol Section:
NCT02704156