NCT05328336

Perioperative Tislelizumab Combined With Nab-Paclitaxel for Muscle-invasive Urothelial Bladder Cancer: A Multicenter Study

A Single-arm, Multicenter, Open Clinical Trial of the Efficacy and Safety of Tislelizumab in Combination With Nab-Paclitaxel for the Perioperative Treatment of Muscle-invasive Bladder Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 74 (estimated)
• Sponsor: Tianjin Medical University Second Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, open-label, multicenter clinical trial to investigate the safety and efficacy of tislelizumab when given in combination with nab-paclitaxel as perioperative treatment in patients with muscle-invasive bladder cancer (MIBC) prior to cystectomy or complete TURBT. Patients will receive perioperative treatment with tislelizumab in combination with nab-paclitaxel every 3 weeks for 3 treatment cycles over 9 weeks followed by radical cystectomy or complete TURBT.

Conditions

• Muscle Invasive Bladder Cancer Urothelial Carcinoma

Interventions

Type	Name	Description
DRUG	Tislelizumab Nab paclitaxel	Drug: Tislelizumab Tislelizumab 200mg will be administered on Day 1 every 3 weeks for 3 cycles Other Names: • BGB-A317 Drug: Nab paclitaxel Nab paclitaxel 200mg will

Timeline

• Start date: 2021-11-11
• Primary completion: 2025-07-01
• Completion: 2025-11-01
• First posted: 2022-04-14
• Last updated: 2022-06-13

Locations

1 site across 1 country: China