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 @ 9:22 PM
Ignite Modification Date:
2025-12-24 @ 9:22 PM
NCT ID:
NCT05222204
Eligibility Criteria:
Inclusion Criteria:
cohort A
Patients should meet the following criteria before treatment to be included in the trial:
1. Voluntarily participate and sign the informed consent;
2. Age ≥18 years old and ≤75 years old, gender is not limited;
3. ECOG score ≤2 points;
4. Pathological diagnosis of pancreatic adenocarcinoma;
5. Advanced pancreatic cancer with intra-abdominal metastasis in imaging assessment, or intra-operative intra-operative findings of intra-abdominal metastasis;
6. The time from the end of adjuvant chemotherapy after surgery is more than 6 months, or they have not received any form of anti-tumor therapy before, including interventional chemoembolization, ablation, radiotherapy, chemotherapy, and molecular targeted therapy;
7. No serious abnormal blood system, heart, lung function and immune deficiency (refer to their respective standards);
8. Blood routine indicators: white blood cells ≥3 × 109/L; absolute neutrophil count ≥1.5 × 109/L; platelets ≥100 × 109/L; hemoglobin ≥9 g/dL;
9. Blood biochemical indexes: AST (SGOT), ALT (SGPT) ≤ 2.5 × upper limit of normal (ULN); total bilirubin (TBIL) ≤ ULN; serum creatinine (CRE) ≤ 1.5 × ULN;
10. Coagulation function: prothrombin time (PT), international normalized ratio (INR) ≤ 1.5 × ULN;
11. Able to comply with research visit plans and other protocol requirements.
inclusion criteria (Cohort B)
Patients should meet the following criteria before treatment to be included in the trial:
1. Voluntarily participate and sign the informed consent;
2. Age ≥18 years old and ≤75 years old, gender is not limited;
3. ECOG score ≤2 points;
4. Pathological diagnosis of pancreatic adenocarcinoma;
5. malignant ascites with positive peritoneal cytology or Laparoscopic exploration processed.
6. At least one systemic chemotherapy has been used;
7. No serious abnormal blood system, heart, lung function and immune deficiency (refer to their respective standards);
8. Blood routine indicators: white blood cells ≥3 × 109/L; absolute neutrophil count ≥1.5 × 109/L; platelets ≥100 × 109/L; hemoglobin ≥9 g/dL;
9. Blood biochemical indexes: AST (SGOT), ALT (SGPT) ≤ 2.5 × upper limit of normal (ULN); total bilirubin (TBIL) ≤ ULN; serum creatinine (CRE) ≤ 1.5 × ULN;
10. Coagulation function: prothrombin time (PT), international normalized ratio (INR) ≤ 1.5 × ULN;
11. Able to comply with research visit plans and other protocol requirements.
Exclusion Criteria:
Patients were excluded from the study if they met any of the following criteria:
1. Associated with other systemic malignant tumors;
2. Single kidney, deformed kidney or poor renal compensation;
3. Have used any other study drug within 7 days before chemotherapy;
4. Patients with central nervous system disease, mental illness, unstable angina pectoris, congestive heart failure, severe arrhythmia and other serious diseases that cannot be controlled;
5. There is a history of allergy to the study drug or drugs of similar structure;
6. Patients who are using and require long-term use of warfarin anticoagulation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05222204
Study Brief:
Protocol Section:
NCT05222204