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:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2025-12-25 @ 4:33 AM
NCT ID:
NCT04707118
Eligibility Criteria:
Inclusion Criteria:
* Participate voluntarily and sign informed consent;
* Age ≥18 years old and ≤80 years old, regardless of gender;
* Physical condition ECOG 0 \~ 2;
* The diagnosis of pancreatic adenocarcinoma was confirmed by pathology;
* Peritoneal metastasis was confirmed by ascites cytology, or was pathologically confirmed by surgical exploration and biopsy;
* Expected survival ≥3 months;
* No serious abnormal blood system, heart and lung function and immune deficiency (refer to respective standards);
* Blood routine indicators: white blood cell (WBC) ≥3 × 109/L;Absolute count of neutrophils (ANC) ≥1.5 × 109/L;Platelet (PLT) ≥100 × 109/L;Hemoglobin (Hgb) ≥9 g/dL;
* Blood biochemical indexes: AST (SGOT) and ALT (SGPT) ≤2.5 × upper limit of normal value (ULN);Total bilirubin (TBIL) ≤ULN;Serum creatinine (CRE) ≤1.5 × ULN;
* Coagulation function: Prothrombin time (PT), international standard ratio (INR) ≤1.5 × ULN;
* Comply with the study visit plan and other program requirements.
Exclusion Criteria:
* Accompanied by other systemic malignant tumors;
* Received any form of anti-tumor therapy, including interventional chemoembolization, ablation, radiotherapy, chemotherapy, tumor palliative resection and molecular targeted therapy;
* Used any other study drugs within 5 weeks before enrollment;
* Central nervous system diseases, mental diseases, unstable angina pectoris, congestive heart failure, severe arrhythmia and other serious diseases that cannot be controlled;
* Uncontrolled infection, bleeding, pancreatic leakage, bile leakage, or other postoperative complications during baseline examination;Acute and chronic metabolic acidosis (including ketoacidosis and lactic acidosis) has not been corrected.
* A history of allergy to study drugs or similar structured drugs;
* Pregnant or lactating women;
* Any conditions, including serious medical risk factors, medical conditions, and laboratory abnormalities, that may impair patient safety or the integrity of research data;
* Intestinal obstruction, extensive adhesion in the peritoneal cavity, abdominal inflammation, etc.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04707118
Study Brief:
Protocol Section:
NCT04707118