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

PHASE3RecruitingINTERVENTIONAL
Enrollment

76

Participants

Timeline

Start Date

June 1, 2023

Primary Completion Date

June 1, 2025

Study Completion Date

June 1, 2035

Conditions
Urinary Bladder NeoplasmsBCG VaccineImmunotherapy, ActiveMulticenter StudyTreatment OutcomeNeoplasm Recurrence, Local
Interventions
DRUG

Tislelizumab 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.

Trial Locations (1)

350000

RECRUITING

Department of Urology, Fujian Union Hospital, Fujian Medical University, Fuzhou

All Listed Sponsors
lead

Fujian Medical University Union Hospital

OTHER