RecruitingNot ApplicableNCT06889623

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

Impact of Immediate Cisplatin/Gemcitabine Chemotherapy Following Resection for High-Risk Non-Muscle-Invasive Bladder Cancer: an Open-label, Single-arm, Prospective Trial

Sponsor

Changhai Hospital

Enrollment

72 participants

Start Date

Jun 1, 2024

Study Type

INTERVENTIONAL

Conditions

NMIBC

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether giving chemotherapy immediately into the bladder right after surgery to remove high-risk non-muscle-invasive bladder cancer (cancer that hasn't grown deep into the bladder wall) reduces the chance of the cancer coming back. **You may be eligible if...** - You have high-risk bladder cancer that hasn't invaded the muscle layer (specific subtypes like high-grade T1, carcinoma in situ, or recurrent high-grade Ta) - You have had BCG immunotherapy that failed - You are in generally good health **You may NOT be eligible if...** - You have bladder cancer that has invaded the muscle wall or spread elsewhere - You have had a bladder perforation during surgery - You are pregnant or have a serious concurrent illness Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREImmediate postoperative chemotherapy

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

Locations(1)

Shanghai Changhai Hospital

Shanghai, Shanghai Municipality, China

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NCT06889623

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