Spots Global Cancer Trial Database for Bladder Sparing Treatment of Tislelizumab, Gemcitabine and Cisplatin for Patients With PD-L1 Positive Muscle Invasive Bladder Cancer

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Trial Identification

Brief Title: Bladder Sparing Treatment of Tislelizumab, Gemcitabine and Cisplatin for Patients With PD-L1 Positive Muscle Invasive Bladder Cancer

Official Title: Bladder Sparing Treatment of Tislelizumab Combined With Gemcitabine and Cisplatin for Patients With PD-L1 Positive Muscle Invasive Bladder Cancer (T2-3N0M0): a Phase II Prospective Study

Study ID: NCT05401279

Conditions

Urothelial Carcinoma Bladder

PD-1 Inhibitor

Interventions

Tislelizumab

Gemcitabine

Cisplatin

Study Description

Brief Summary: This is a phase II open label single-arm prospective study aiming to investigate the efficacy of PD-1 inhibitor Tislelizumab combined with conventional gemcitabine and cisplatin as bladder sparing treatment for patients with PD-L1 positive muscle invasive bladder carcinoma (T2-3N0M0).

Detailed Description: The study will enroll 20 patients with adequate organ function and performance status who either wish to attempt bladder preserving therapy or are ineligible for radical cystectomy. The bladder samples must be available and assessed as positive for PD-L1 expression . Patients will receive transurethral resection or partial cystectomy to remove all visible tumors with no residual disease left. After the surgery, patients will receive 8 cycles of tislelizumab combined with 4-6 cycles of gemcitabine and cisplatin.