drugset / Trial / NCT06861192

Clinical Study of Fasudil Hydrochloride and PD1 Inhibitor Combined With Androgen Deprivation in Neoadjuvant Therapy of Prostate Cancer

NCT06861192

Phase 2/3 Recruiting 83 enrolled baotai Liang
RandomizedCrossoverOpen-labelTreatment

Summary

The high incidence of prostate cancer is one of the important diseases that threaten the health of old men in our country. Although androgen deprivation therapy is an important treatment option for prostate cancer, although neoadjuvant androgen deprivation therapy combined with radical prostatectomy reduced the positive rate of surgical margins, it did not show statistically significant improvement in prostate-specific antigen (PSA). At the same time, few trials reported pathological complete response (pCR) and minimal residual lesion (MRD). The purpose of this project is to verify the therapeutic effect of fasudil hydrochloride and PD1 inhibitor combined with androgen deprivation in patients with locally advanced prostate cancer or oligometastatic prostate cancer before radical prostatectomy through randomized controlled clinical trials, so as to find an effective treatment for locally advanced prostate cancer or oligometastatic prostate cancer.

Timeline

Start
2025-02-16
Primary completion
2026-03-16
Completion
2027-03-16

Drugs

EvaluationDrugModalityDoseRoute
Subject Fasudil Small molecule 10 mg
Subject triprilizumab Unknown 3 mg/kg Intravenous

Indications