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

NCT06889623 · tracked via the Priya Life Science China tracker

Sponsor

Changhai Hospital

Phase

Not applicable

Started

2024-06-01

Last updated

2025-03-21

Condition(s) studied

NMIBC

Investigational drug(s) / intervention(s)

Immediate postoperative chemotherapy

Immediate postoperative chemotherapy: Systemic chemotherapy with cisplatin/gemcitabine intravenous infusion within 24 hours after TURBT

Study 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 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

One-year recurrence-free survival rate — About two years after the first immediate chemotherapy
The percentage of patients who remain cancer-free for one year after treatment.

Trial sites (1)

Facility	City	Region	Status
Shanghai Changhai Hospital	Shanghai	Shanghai Municipality	Recruiting

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Other trials for the same condition

A Study of Intravesical SHR-1501 Combination With BCG Versus Investigator-selected Chemotherapy in Subjects With BCG-unresponsive NMIBC Recruiting

A Multicenter Prospective Cohort Study on Monitoring Recurrence of Urothelial Carcinoma Based on Detection of Urinary Microscopic Residual Disease (MRD) Recruiting

A Clinical Trial Evaluating the Efficacy and Safety of Disitamab Vedotin Plus Tislelizumab Combined with Re-TURBT in the Treatment of HER-2-high Expression(2+-3+) Non-muscle Invasive Bladder Cancer At High-risk and Very High-risk. Starting soon

SHR-1501 Combined With SHR-2005 for High-Risk Non-Muscle Invasive Bladder Cancer Which is Not Completely Resectable by TURBt Starting soon

Trop2-Targeted Near-Infrared Fluorescence Imaging-Guided Precise Resection of Non-Muscle Invasive Bladder Cancer Starting soon

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06889623 on ClinicalTrials.gov ↗ ← All trials in China