RecruitingPhase 3NCT06441110

Multicenter Clinical Trial on the Effectiveness and Safety of Instillation of BCG and Alternative BCG Protocols for Intermediate and High-risk Non-muscle Invasive Bladder Cancer

Multicentre Clinical Trial of the Efficacy and Safety of Tislelizumab in Combination With BCG Bladder Instillation in the Prevention of Postoperative Recurrence in Intermediate and High-risk Non-muscle Invasive Bladder Cancer

Sponsor

Fujian Medical University Union Hospital

Enrollment

76 participants

Start Date

Jun 1, 2023

Study Type

INTERVENTIONAL

Conditions

Urinary Bladder Neoplasms Treatment Outcome Immunotherapy, Active BCG Vaccine Multicenter Study Neoplasm Recurrence, Local

Summary

Previous studies have reported the efficacy of Bacillus Calmette-Guérin (BCG) combined with other drugs for the treatment of bladder cancer. However, research on the combination of tislelizumab and BCG for bladder cancer treatment has largely been retrospective. Currently, ongoing clinical trials have not discussed the effectiveness of PD-1/PD-L1 inhibitors combined with BCG instillation in reducing postoperative recurrence in intermediate-risk NMIBC. Therefore, this study aims to explore the clinical efficacy and safety of tislelizumab combined with BCG in the treatment of intermediate and high-risk NMIBC. For this purpose, investigators have established strict screening criteria to include eligible patients in the study and have recruited suitable patients from multiple medical centers.Investigators have also developed a meticulous implementation process and follow-up considerations, hoping to better verify the clinical efficacy and safety of the combined use of these two drugs.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study compares different treatment schedules for BCG therapy — a common immunotherapy instilled directly into the bladder to treat bladder cancer — in people with intermediate or high-risk non-muscle-invasive bladder cancer (cancer that has not yet grown into the bladder wall muscle). **You may be eligible if...** - You are between 18 and 75 years old - You have been confirmed by biopsy to have non-muscle-invasive bladder cancer - Your tumor tests positive for PD-L1 (a protein on cancer cells) - Your expected survival is at least 2 years - You have signed informed consent **You may NOT be eligible if...** - Your cancer has grown into the muscle of the bladder - You have had a severe reaction to BCG therapy in the past - You have active tuberculosis or a weakened immune system - You are pregnant or breastfeeding 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGTislelizumab in Combination with Bacillus Calmette-Guérin

Postoperative immediate instillation of epirubicin (50mg) is administered. Postoperatively, 200mg of tislelizumab injection is given intravenously every 3 weeks, with each 21-day period constituting one cycle. The medication is administered on day 1 of each cycle, continuing for one year. Eligible patients for the single-arm group (N = 76) begin BCG instillation after 2 weeks, with a dosage of 120mg per instillation, totaling 19 instillations: this starts with a 6-week induction phase of weekly BCG instillations, followed by BCG instillations every 2 weeks for three consecutive times; thereafter, maintenance instillation therapy commences, involving monthly BCG instillations for a total of ten times.