Bladder Cancer
Conditions
Interventions
Test Group :LDH/EDTA Combined with Mitomycin C
Sponsors
Shanghai Tenth People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years; 2. Pathologically confirmed intermediate- or high-risk non-muscle-invasive bladder cancer (Ta, T1 stage, or carcinoma in situ); 3. Completion of transurethral resection of bladder tumor (TURBT) with no macroscopically visible residual tumor post-operatively; 4. Good physical condition (ECOG score 0-1) and life expectancy > 3 months; 5. Essentially normal results of blood tests, liver and kidney function, and coagulation function; 6. No active infections (e.g., urinary tract infection, tuberculosis, active hepatitis, etc.); 7. No severe cardiovascular/cerebrovascular diseases or immune system disorders; 8. Women of childbearing potential must have a negative pregnancy test and agree to use contraception during the study period.
Exclusion criteria
Exclusion criteria: 1. The tumor has invaded the bladder muscle layer or metastasized. 2. Recent (within 4 weeks) receipt of other anti-tumor therapy or major surgery. 3. Presence of gross hematuria or active urinary tract infection at the time of screening. 4. Known allergy to mitomycin C or any component of LDH/EDTA. 5. Uncontrolled hypertension, severe arrhythmia, or other cardiovascular/cerebrovascular diseases 6. History of psychiatric disorders, alcoholism, or drug abuse. 7. Any other condition considered by the investigator to be unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS);Safety and Tolerability During Treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| 12-Month Recurrence Rate;Complete Response Rate;Disease Progression Rate;Overall Survival;Time to Treatment Failure;Bladder Preservation Rate; | — |
Countries
China
Contacts
Public ContactBing Shen
Shanghai Tenth People's Hospital
Outcome results
None listed