NCT04730219

Perioperative Tislelizumab Combined With Nab-Paclitaxel for Muscle-invasive Urothelial Bladder Carcinoma

An Open Label, Single-arm, Phase 2 Study of Perioperative Tislelizumab Combined With Nab-Paclitaxel Before Cystectomy or Complete TURBT for Patients With Muscle-invasive Urothelial Bladder Cancer.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Tianjin Medical University Second Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II study to determine 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 treatment with tislelizumab in combination with nab-paclitaxel every 3 weeks for 3 treatment cycles over 9 weeks followed by standard radical cystectomy or complete TURBT.

Conditions

• Muscle Invasive Bladder Cancer
• Urothelial Carcinoma

Interventions

Type	Name	Description
DRUG	Tislelizumab	Tislelizumab 200mg will be administered on Day 1 every 3 weeks for 3 cycles
DRUG	Nab paclitaxel	Nab paclitaxel 200mg will be administered on Day 2 every 3 weeks for 3 cycles

Timeline

• Start date: 2020-07-11
• Primary completion: 2024-02-01
• Completion: 2024-07-01
• First posted: 2021-01-29
• Last updated: 2022-11-30

Locations

1 site across 1 country: China