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Search / Trial NCT06889623

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.

Locations

Shanghai, Shanghai, China

Patients applied

0 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