Status:
RECRUITING
Immediate Chemotherapy Following Resection for High-Risk Non-Muscle-Invasive Bladder Cancer
Lead Sponsor:
Changhai Hospital
Conditions:
NMIBC
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Residual tumors after transurethral resection of bladder tumors (TURBT) range from 17-70%, and floating tumor cells from traditional segmental resection may lead to recurrence if they re-implant in th...
Detailed Description
Bladder cancer ranks as the ninth most prevalent cancer globally, with urothelial carcinoma being the primary form, leading to over 220,000 deaths annually. While 70-75% of bladder cancer cases initia...
Eligibility Criteria
Inclusion
- Patients with a history and cystoscopy results indicating high-risk NMIBC:
- High-grade T1
- Any recurrent high-grade Ta
- High-grade Ta \& Tumor diameter greater than 3 cm or multifocal
- Any CIS
- Any BCG failure in patients with high-grade disease
- Any variant histology
- Any LVI
- Any high-grade prostatic urethral involvement
- Patients in generally good condition with a follow-up period of 2 years
Exclusion
- Bladder cancer other than UC
- MIBC or benign diseases
- Incomplete tumor resection
- Active infection
- Concurrent upper urinary tract or prostatic urethral UC
- Previous systemic chemotherapy, immunotherapy, or radiotherapy
- Leukopenia/thrombocytopenia
- Serum creatinine greater than twice the normal level
- Uncontrollable urinary tract infection
Key Trial Info
Start Date :
June 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT06889623
Start Date
June 1 2024
End Date
June 1 2028
Last Update
March 21 2025
Active Locations (1)
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1
Shanghai Changhai Hospital
Shanghai, Shanghai Municipality, China, 200000