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 @ 10:48 PM
Ignite Modification Date:
2025-12-24 @ 10:48 PM
NCT ID:
NCT04567069
Eligibility Criteria:
Inclusion Criteria:
1. Pathologically or cytologically confirmed gastric adenocarcinoma.
2. Patients should be within age range of ≥18 and ≤80 years old, competent, have signed informed consent and have a life expectancy greater than 6 months.
3. Failed in previous standard therapy ( surgery, chemotherapy, radiotherapy, and targeted therapy) or recurred from previous therapy, patients must be at least 1 month from their last therapy.
4. Patients without indications of surgery, radiotherapy or chemotherapy.
5. Patients who can't tolerate radiotherapy or chemotherapy.
6. Patients who refuse radiotherapy or chemotherapy.
7. Have measurable lesion by RECIST 1.1 criteria.
8. Karnofsky Performance Status (KPS) ≥60.
9. Patients must be willing to enroll the clinical study, and comply with the study and follow-up procedures.
10. Adequate organ and bone marrow functions:
1. White Blood Count (WBC) ≥ 3,000/mm3 (3.0×109/L);
2. Neutrophils≥ 1,000/mm3 (1.0×109/L);
3. Platelets (PLT) ≥ 80,000/mm3 (80×109/L);
4. Hemoglobin（Hb）≥ 9 g/dL (90g/L);
5. Serum creatinine ≤ 1.5x the upper limit of normal (ULN) or creatinine clearance (CrCl)≥ 40 mL/min;
6. Bilirubin≤ 1.5x ULN;
7. Aspartate Aminotransferase (AST) ≤ 2.5x ULN or Alanine Aminotransferase (ALT) ≤ 2.5x ULN; patients with liver metastasis must be ≤5x ULN;
8. International normalized ratio (INR) ≤ 1.5, prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 times ULN;
9. Urine protein \< 2 +; if urinary protein ≥ 2 +, the 24-hour urine protein quantification must be ≤ 1g.
Exclusion Criteria:
1. Other diseases that may have influence on this study ( such as active infection, symptomatic myocardial infarction, angina pectoris, arrhythmia, etc.).
2. Patients who received systemic anti-tumor therapy and local treatment (radiotherapy, ablation and embolization) for gastric cancer within 1 month.
3. Patients who have active autoimmune diseases and need systemic immunosuppressive therapy.
4. Life expectancy \< 6 months.
5. Patients with organ allografts.
6. Women who are pregnant or nursing/breastfeeding
7. Allergic to allogeneic protein.
8. Human immunodeficiency virus (HIV) infection, untreated active hepatitis (hepatitis B, defined as HBV-DNA ≥ 500 IU / ml; hepatitis C, defined as HCV-RNA higher than the detection limit of the analytical method).
9. For any other reasons, the patients are believed not suitable for participation in this study by investigators .
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04567069
Study Brief:
Protocol Section:
NCT04567069