NCT04562311

Chidamide With Immunotherapy for Patients With Locally Advanced or Metastatic Urothelial Carcinoma

The Efficacy and Safety of Chidamide Combined With Immunotherapy in Patients With Locally Advanced or Metastatic Urothelial Carcinoma Who Had Previously Received Platinum-based Chemotherapy:An Open, One-arm, Phase II Study

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Study of Chidamide Combined With Immunotherapy in Patients With Locally Advanced or Metastatic Urothelial Carcinoma Who Had Previously Received Platinum-based Chemotherapy

Detailed description

Chidamide has been approved for the treatment of relapsed or refractory peripheral T-cell lymphoma in China (Chidamide,a novel histone deacetylase inhibitor). Tirelizumab,has been approved for the failure treatment of platinum-containing chemotherapy with high PD-L1 expression included locally advanced or metastatic Urothelial carcinoma in China(Tirelizumab,BGB-A317 is an investigational humanized IgG4 anti-PD-1 monoclonal antibody ).The aim of this study was to observe the efficacy and safety of Chidamide with Immunotherapy in patients with progression of platinum-based chemotherapy recurrent and metastatic Urothelial carcinoma.

Conditions

• Bladder Cancer Stage IV

Interventions

Type	Name	Description
DRUG	Chidamide	Chidamide: 30mg orally BIW. Immunotherapy: tislelizumab,the fixed dose of 200 mg IV. Treatment cycles are repeated every 3 weeks.

Timeline

• Start date: 2021-01-01
• Primary completion: 2024-08-30
• Completion: 2025-10-30
• First posted: 2020-09-24
• Last updated: 2024-12-04

Locations

1 site across 1 country: China