NCT05401279

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urothelial Carcinoma Bladder
• PD-1 Inhibitor

Interventions

Type	Name	Description
DRUG	Tislelizumab	Tislelizumab 200mg will be administered on Day 1 of each 21 day cycle for 8 21-day cycles.
DRUG	Gemcitabine	Gemcitabine 1000mg/m\^2 will be administered on Days 1 and 8 for four to six 21-day cycles.
DRUG	Cisplatin	Cisplatin 70mg\^m2 will be administered on Day 1 for four to six 21-day cycles.

Timeline

• Start date: 2022-06-01
• Primary completion: 2024-04-01
• Completion: 2025-05-01
• First posted: 2022-06-02
• Last updated: 2022-08-18

Locations

1 site across 1 country: China