Bladder cancer
Conditions
Interventions
Control group:The control group received intravesical induction instillation after surgery. The instillation drug was epirubicin (50mg), once a week for 8 consecutive times
followed by intravesical continuous instillation, once a month for 6 consecutive times.
Treatment group:The control group received intravesical induction perfusion after surgery, with epirubicin as the perfusion drug. The treatment group received intravesical perfusion of epirubicin (50m
Sponsors
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Clinical diagnosis of non-muscle-invasive bladder cancer (NMIBC) must meet the following criteria: 1. Age >=18 years and <=80 years, either sex; 2. Voluntary participation with signed informed consent; 3. ECOG performance status of 0–1; 4. First-time diagnosis without prior systemic treatment, confirmed by imaging and pathology as low- or intermediate-risk NMIBC, including Ta and T1 stages; 5. Traditional Chinese Medicine diagnosis as "Shi-Re" (damp-heat) syndrome.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; 2. Severe infection; 3. Severe heart disease; 4. Uncontrolled neurological or psychiatric disorders; 5. Severe diabetes; 6. Severe autoimmune diseases; 7. Other serious conditions deemed by the investigator to affect follow-up or short-term survival, or any medical condition suggesting a significant risk of death during the one-year study period; 8. History of any other prior malignancy; 9. Patients with muscle-invasive bladder cancer (MIBC) following transurethral resection of bladder tumor (TURBT), including stage T2 or higher; 10. Patients receiving concurrent therapies other than intravesical chemotherapy (e.g., systemic chemotherapy, immunotherapy, etc.); 11. Any other condition deemed unsuitable for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| II and III degree urinary tract irritation symptoms;The proportion of WBC <= 20/HP in the urine routine test of asymptomatic patients; | — |
Secondary
| Measure | Time frame |
|---|---|
| Whether oral Babao Powder has the potential to serve as an adjuvant therapy for preventing recurrence in patients undergoing postoperative intravesical chemotherapy for bladder cancer.;Functions of metabolites differing among postoperative bladder cancer patient groups and the metabolic pathways they are involved in.; | — |
Countries
China
Contacts
Public ContactZhang Lianhua
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed