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 @ 2:49 PM
Ignite Modification Date:
2025-12-24 @ 2:49 PM
NCT ID:
NCT04060459
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥ 18 years.
2. Patients must have histologically confirmed resectable（stage T2，T3 and T4a） urothelial carcinoma following 2017 V8 AJCC，including renal pelvic carcinoma，ureteral carcinoma，bladder carcinoma and urethral carcinoma.
3. There was at least one measurable tumor lesion following RECIST 1.1.
4. Treatment naïve.
5. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
6. Left ventricular ejection fraction≥50%.
7. Absolute neutrophil count (ANC) ≥ 1.5 × 109/L，platelets (PLT) ≥ 100 × 109/L，hemoglobin (Hb) ≥ 90 g/L，leucocyte ≥ 3.0 × 109/L.
8. Total bilirubin (TBIL) ≤ 1.5 ×institutional upper limit of normal (ULN)， Alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase \[SGPT\]) /Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]≤ 2.5 ×ULN ，Creatinine (CRE) ≤ 1.5 ×ULN.
9. Signed informed content obtained prior to treatment.
Exclusion Criteria:
1. Patients who are pregnant or may be pregnant or nursing.
2. Patients with Coagulation dysfunction or active internal hemorrhage.
3. Patients with uncontrolled active infection，HIV，viral hepatitis.
4. Peripheral nerve lesion≥grade 1 following NCI-CTC 5.0.
5. Patients with serious cardiovasculardisease including history of cerebral vascular accident ， myocardial infarction，hypertension，angina，heart failure（NYHA grade 2-4） within the last 6 months.
6. History of allergic reactions attributed to compounds of similar chemical or biological composition to drugs used in this study.
7. Patients was involved in another study within the last 30 days.
8. Patients was mental disorders.
9. Any other patients deemed by the attending physician to be unsuitable to allow the feasible for this study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04060459
Study Brief:
Protocol Section:
NCT04060459