NCT07261592

Entinostat & Chemotherapy for Locally Advanced or Metastatic Bladder Cancer

Entinostat Combined With Chemotherapy as Second-line Therapy for Unresectable Locally Advanced or Metastatic Bladder Cancer: A Single-arm, Prospective Clinical Trial

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 29 (estimated)
• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This single-center single-arm, open-label prospective clinical trial aimed to evaluate the efficacy and safety of entinostat combined with chemotherapy as second-line therapy for unresectable locally advanced or metastatic bladder cancer.

Conditions

• Bladder Cancer
• Histone Deacetylase Inhibitor
• Entinostat
• Chemotherapy

Interventions

Type	Name	Description
DRUG	Entinostat	Take entinostat 5mg orally once weekly (at least 1 hour before meal and 2 hours after meal).
DRUG	Chemotherapy	Gisantinib and cisplatin chemotherapy for 6 cycles, 21 days per cycle. Gisantinib 1000mg/m2 is given intravenously on Day 1 and 8 for each cycle while cisplatin 70mg/m2 is given intravenously on Day2.

Timeline

• Start date: 2025-12-01
• Primary completion: 2028-09-30
• Completion: 2029-04-30
• First posted: 2025-12-03
• Last updated: 2025-12-03

Locations

1 site across 1 country: China