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 @ 2:20 AM
Ignite Modification Date:
2025-12-25 @ 2:20 AM
NCT ID:
NCT03822234
Eligibility Criteria:
Inclusion Criteria:
1. Age 18-75 years old, gender not limited, life expectancy is greater than or equal to 24 months；
2. ECOG score of patients: 0-1；
3. Volunteer to participate in this study and sign the informed consent；
4. T2-T4a, N0-x,M0 invasive bladder cancer; High risk non-muscular invasive bladder cancer T1G3(high grade) tumor; Tis in which BCG therapy failed; Recurrent non-invasive bladder cancer; TUR and bladder perfusion were used for treatment of uncontrolled extensive papillary lesions and bladder non-urothelial carcinoma;
5. Major organ functions, such as liver, kidney, bone marrow, heart and other important organs, were not significantly abnormal: AST, ALT≤2.5 upper limit of normal value (ULN); Total bilirubin (TBIL)≤1.5 ULN; Albumin (ALB)≥25g/L; Serum creatinine (CRE)≤1.5 ULN; Leukocytes≥3.5\*109/L, neutrophils≥1.5\*109/L, hemoglobin≥90g/L, platelets≥80\*109/L; Left ventricular ejection fraction (LVEF) ≥50%; Electrocardiogram showed no obvious abnormality or no clinical significance.
Exclusion Criteria:
1. A history of major middle and lower abdominal surgery;
2. Obese patients （BMI≥40kg/m2）;
3. Failure to receive regular follow-up review as required;
4. Severe cardiovascular disease;
5. History of immunodeficiency and organ transplantation；
6. History of severe central nervous system disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03822234
Study Brief:
Protocol Section:
NCT03822234