NCT04099589

Neoadjuvant Treatment of Upper Urinary and Muscular Invasive Bladder Urothelial Carcinoma

Multicenter Phase II Study of Gemcitabine/Cisplatin (GC) Chemotherapy Combined With PD-1 Inhibitor (Toripalimab) in the Neoadjuvant Treatment of Upper Urinary and Muscular Invasive Bladder Urothelial Carcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Few previous studies focused on the neoadjuvant treatments of upper urinary or bladder cancer, especially chemotherapy combined with immunotherapy, however, available data of retrospective studies showed this neoadjuvant treatment model might benefit patients. So This prospective Phase II clinical trial was designed to explore the efficacy of chemotherapy combined with PD-1 inhibitor as neoadjuvant therapy in upper urinary and muscle-invasive bladder urothelial carcinoma, then to improve the rate of complete pathological remission, survival and provide medical evidence.

Conditions

• Upper Tract Urinary Carcinoma
• Muscle-invasive Bladder Cancer

Interventions

Type	Name	Description
DRUG	Toripalimab	Gemcitabine/Cisplatin plus Toripalimab

Timeline

• Start date: 2019-10-01
• Primary completion: 2022-10-01
• Completion: 2022-10-01
• First posted: 2019-09-23
• Last updated: 2022-03-29

Locations

1 site across 1 country: China