NCT07451795

SHR-1701 in Combination With Stereotactic Body Radiotherapy in mCRPC

A Prospective, Randomized, Controlled Phase II Study of SHR-1701 in Combination With Stereotactic Body Radiotherapy (SBRT) for Metastatic Castration-Resistant Prostate Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: Male
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to evaluate the efficacy of SHR-1701 in combination with SBRT in patients with metastatic castration-resistant prostate cancer. Dr. Yao Zhu from Fudan University Shanghai Cancer Center is the co-leading PI of this study.

Conditions

• Prostate Cancer
• mCRPC (Metastatic Castration-resistant Prostate Cancer)

Interventions

Type	Name	Description
COMBINATION_PRODUCT	SHR-1701 + SBRT	Stereotactic body radiotherapy on targeted metastasis determined by MDT + SHR1701 30mg/kg IV every 3 weeks (Q3W) for 2 cycles, then SHR1701 alone Q3W until progression
RADIATION	SBRT	Stereotactic body radiotherapy on targeted metastasis determined by MDT

Timeline

• Start date: 2026-03-02
• Primary completion: 2028-03-31
• Completion: 2028-12-31
• First posted: 2026-03-05
• Last updated: 2026-03-05

Locations

3 sites across 1 country: China