RecruitingPhase 2NCT07451795

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


Sponsor

Fudan University

Enrollment

66 participants

Start Date

Mar 2, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether combining an immunotherapy drug (SHR-1701, which blocks a protein that helps cancer hide from the immune system) with targeted radiation therapy (SBRT—high-dose radiation aimed precisely at a small number of tumors) can help men with advanced prostate cancer that has stopped responding to hormone treatments. **You may be eligible if...** - You are between 18 and 80 years old and have confirmed advanced prostate cancer - Your cancer has stopped responding to at least one type of hormone-blocking drug - You have also received docetaxel chemotherapy or have a documented reason you cannot - Your testosterone levels are maintained at very low (castrate) levels - You have adequate blood counts, liver, kidney, and heart function **You may NOT be eligible if...** - You have cancer that has spread to the brain - You have received immunotherapy (checkpoint inhibitors) before - You have an active autoimmune disease requiring systemic treatment - You have significant neurological or psychiatric disorders - You have had recent radiation therapy or certain hormone treatments Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

COMBINATION_PRODUCTSHR-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

RADIATIONSBRT

Stereotactic body radiotherapy on targeted metastasis determined by MDT


Locations(3)

Fujian Cancer Hospital

Fujian, China

Fudan University Shanghai Cancer Center

Shanghai, China

Fudan University Shanghai Cancer Center Xiamen Branch

Xiamen, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07451795


Related Trials