NCT07250542

A Clinical Study on the Efficacy and Safety of Fasudil Hydrochloride Combined With Immunotherapy in the Treatment of Metastatic Castration-resistant Prostate Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: baotai Liang · Academic / Other
• Sex: Male
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Carrying out clinical trials of salbutamol hydrochloride combined with immunotherapy and castration for the treatment of prostate cancer is of great significance. Firstly, it can verify the efficacy and safety of this combination in the treatment of prostate cancer, providing a scientific basis for its clinical application. Secondly, through clinical trials, the mechanism of action of salbutamol hydrochloride combined with immunotherapy can be further studied. Finally, this clinical trial can further expand the treatment strategies for prostate cancer.

Detailed description

This study is a single-arm clinical trial. Eligible patients will be included in the group receiving farsufilide hydrochloride combined with immunotherapy. After enrollment, in addition to the routine androgen deprivation therapy, they will also receive farsufilide hydrochloride (10mg intravenous infusion) on days 1-5, and PD-1 monoclonal antibody (Tirapibep, 3mg/kg, intravenous infusion) on day 5. The treatment will be repeated every 21 days for a total of 4 times.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Fasudil hydrochloride combined with immunotherapy	This study is a single-arm clinical trial. Eligible patients will be included in the group receiving farsufilide hydrochloride combined with immunotherapy. After enrollment, in addition to the routine use of castration therapy, they will also receive farsufilide hydrochloride (10mg intravenous infusion) on days 1-5, and PD-1 monoclonal antibody (Tirapibep, 3mg/kg, intravenous infusion) on day 5. The treatment will be repeated every 21 days for a total of 4 times.

Timeline

• Start date: 2024-07-05
• Primary completion: 2025-12-30
• Completion: 2026-12-30
• First posted: 2025-11-26
• Last updated: 2025-11-26

Locations

1 site across 1 country: China