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Immediate Chemotherapy Following Resection for High-Risk Non-Muscle-Invasive Bladder Cancer

RecruitingNAAges 18 Years - anyAllChanghai Hospital
NCT06889623 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 the bladder wall. Immediate systemic chemotherapy post-surgery aims to eliminate microlesions promptly and minimize recurrence risk, yet its safety and efficacy require further exploration. This prospective, single-arm study delves into evaluating the efficacy and safety of immediate postoperative systemic chemotherapy in patients with suspected high-risk non-muscle-invasive bladder cancer.

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📋 Eligibility rules (as published)
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
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What it tests

  • Immediate postoperative chemotherapy
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Where

1 site
Shanghai Changhai Hospital
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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