Objective To evaluate the efficacy and safety of tislelizumab intravenous injection combined with pirarubicin intravesical instillation in the treatment of non-muscle-invasive bladder cancer(NMIBC).Methods This study is a randomized controlled trial,including 80 patients with NMIBC who underwent transurethral resection of bladder tumor(TURBT)at the urology department of Central Hospital of Guangdong Nongken from January 1,2021,to December 31,2022.The patients were randomly assigned to either the experi-mental group(treated with tislelizumab intravenous injection combined with pirarubicin intravesical instillation,n=40)or the control group(treated with pirarubicin intravesical instillation alone,n=40).The primary efficacy endpoints included progression-free survival(PFS),recurrence rate,and radiological progression rate.Safety was assessed by the type and incidence of treatment-related adverse e-vents(AEs).Results The median PFS in the experimental group was significantly longer than that in the control group(16 months vs 9months,P=0.034).The 1-year and 2-year recurrence rates in the experimental group were significantly lower than in the control group(7.5％vs 15.0％,P=0.034;12.5％ vs 22.5％,P=0.019).The radiological progression rate in the experimental group was significantly lower than that in the control group(7.5％vs20.0％,P=0.019).No treatment-related deaths occurred in either group.The incidence of fatigue was significantly higher in the experimental group than in the control group(25.0％vs 10.0％,P=0.048),while other adverse events showed no significant differences and were predominantly mild to moderate(Grade 1-2),manageable with symptomatic treatment.Conclusion Tislelizumab intravenous injection combined with pirarubicin intravesical instillation significantly prolongs PFS,reduces recurrence rates,and inhibits tumor progression in NMIBC patients,with good safety and tolerability.This combi-nation offers a safe and effective new strategy for postoperative NMIBC management.

Objective To evaluate the efficacy and safety of tislelizumab intravenous injection combined with pirarubicin intravesical instillation in the treatment of non-muscle-invasive bladder cancer(NMIBC).Methods This study is a randomized controlled trial,including 80 patients with NMIBC who underwent transurethral resection of bladder tumor(TURBT)at the urology department of Central Hospital of Guangdong Nongken from January 1,2021,to December 31,2022.The patients were randomly assigned to either the experi-mental group(treated with tislelizumab intravenous injection combined with pirarubicin intravesical instillation,n=40)or the control group(treated with pirarubicin intravesical instillation alone,n=40).The primary efficacy endpoints included progression-free survival(PFS),recurrence rate,and radiological progression rate.Safety was assessed by the type and incidence of treatment-related adverse e-vents(AEs).Results The median PFS in the experimental group was significantly longer than that in the control group(16 months vs 9months,P=0.034).The 1-year and 2-year recurrence rates in the experimental group were significantly lower than in the control group(7.5％vs 15.0％,P=0.034;12.5％ vs 22.5％,P=0.019).The radiological progression rate in the experimental group was significantly lower than that in the control group(7.5％vs20.0％,P=0.019).No treatment-related deaths occurred in either group.The incidence of fatigue was significantly higher in the experimental group than in the control group(25.0％vs 10.0％,P=0.048),while other adverse events showed no significant differences and were predominantly mild to moderate(Grade 1-2),manageable with symptomatic treatment.Conclusion Tislelizumab intravenous injection combined with pirarubicin intravesical instillation significantly prolongs PFS,reduces recurrence rates,and inhibits tumor progression in NMIBC patients,with good safety and tolerability.This combi-nation offers a safe and effective new strategy for postoperative NMIBC management.