Immediate chemotherapy after bladder tumor removal for high-risk patients
Impact of Immediate Cisplatin/Gemcitabine Chemotherapy Following Resection for High-Risk Non-Muscle-Invasive Bladder Cancer: an Open-label, Single-arm, Prospective Trial
This study tests if giving immediate chemotherapy after bladder tumor removal can help high-risk patients avoid cancer recurrence.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Changhai Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06889623 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of administering immediate systemic chemotherapy following the surgical resection of high-risk non-muscle-invasive bladder cancer (NMIBC). The focus is on patients who have undergone transurethral resection of bladder tumors (TURBT) and are at risk of residual tumors that could lead to recurrence. By using a regimen of gemcitabine and cisplatin within 24 hours post-surgery, the study aims to eliminate floating tumor cells and reduce the likelihood of cancer returning. The trial is prospective and single-arm, meaning all participants will receive the same treatment without a control group.
Who should consider this trial
Good fit: Ideal candidates include patients with high-risk NMIBC, such as those with high-grade tumors or those who have experienced BCG treatment failure.
Not a fit: Patients with muscle-invasive bladder cancer or those with incomplete tumor resections will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the recurrence rates of high-risk NMIBC, improving patient outcomes.
How similar studies have performed: Previous studies have shown promise in using immediate chemotherapy post-surgery for bladder cancer, but this specific approach is still being evaluated for its safety and efficacy.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Shanghai, Shanghai Municipality
- Shanghai Changhai Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Principal investigator: Shuxiong Zeng, M.D. Ph.D — Department of Urology, Changhai Hospital, Naval Medical University, Shanghai, China
- Study coordinator: Shuxiong Zeng, M.D. Ph.D
- Email: zengshuxiong@126.com
- Phone: +8618930568759
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.