Immediate Chemotherapy Following Resection for High-Risk Non-Muscle-Invasive Bladder Cancer
Launched by CHANGHAI HOSPITAL · Mar 16, 2025
Trial Information
Current as of July 09, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the use of immediate chemotherapy right after surgery for patients with high-risk non-muscle-invasive bladder cancer (NMIBC). After surgery, some patients may still have small tumors that can grow back. The goal of this trial is to see if giving chemotherapy right away can help kill these tiny tumors and reduce the chance of cancer coming back. The study is currently looking for participants to understand how safe and effective this treatment approach is.
To be eligible for the trial, patients should have specific types of high-risk NMIBC, such as high-grade tumors or cancers that have returned after treatment. Patients must be generally healthy and able to commit to follow-up visits for two years. If you or someone you know fits these criteria, participating in this trial could help advance knowledge about treating bladder cancer and might provide access to new treatment options.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- * 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 Criteria:
- • 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
About Changhai Hospital
Changhai Hospital is a leading medical institution dedicated to advancing healthcare through innovative research and clinical trials. With a commitment to excellence, the hospital integrates cutting-edge medical technologies and a multidisciplinary approach to patient care. Changhai Hospital actively collaborates with research organizations and healthcare professionals to conduct rigorous clinical trials aimed at developing new treatments and improving patient outcomes. By prioritizing patient safety and ethical standards, the hospital plays a pivotal role in contributing to the advancement of medical knowledge and the enhancement of therapeutic options.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Shanghai, Shanghai, China
Patients applied
Trial Officials
Shuxiong Zeng, M.D. Ph.D
Principal Investigator
Department of Urology, Changhai Hospital, Naval Medical University, Shanghai, China
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported