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Clinical Trials in China / NCT06889623
Recruiting Not applicable

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
No
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)

FacilityCityRegionStatus
Shanghai Changhai Hospital Shanghai Shanghai Municipality Recruiting

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THE TRAVEL II TRIAL: Transcatheter Right Atrial-ventricular Valve rEplacement With LuX-Valve Via Jugular Vein Recruiting
Neoadjuvant Chemotherapy in High - Risk Upper Tract Urothelial Carcinoma Starting soon
Pre-Packaged Low-Residue Diet Assisting Bowel Preparation in Patients With Inflammatory Bowel Disease Recruiting

Other trials for the same condition

Trop2-Targeted Near-Infrared Fluorescence Imaging-Guided Precise Resection of Non-Muscle Invasive Bladder Cancer 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
A Multicenter Prospective Cohort Study on Monitoring Recurrence of Urothelial Carcinoma Based on Detection of Urinary Microscopic Residual Disease (MRD) Recruiting
RC48-ADC in Combination With Gemcitabine in High Risk NMIBC Subjects Recruiting
DV+BCG in HER2-Expressing, BCG-Naïve High-Risk NMIBC Recruiting
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