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NCT07240610: AURICRE

Abscopal Effect of Ultra-Hypofractionated Radiation Plus Immunotherapy in Metastatic Renal Cell Carcinoma

Recruiting now Last updated 5 December 2025
What this trial tests

trial in Renal Cell Cancer Metastatic in 145 participants. Currently enrolling.

Timeline
10 November 2025
Primary endpoint
31 March 2028
30 September 2029

Quick facts

Lead sponsorZhe Chen
StatusRecruiting now
Study typeOBSERVATIONAL
Enrollment145
Start date10 November 2025
Primary completion31 March 2028
Estimated completion30 September 2029
Sites1 location across Japan

Conditions studied

Sponsor

Zhe Chen

Who can join

18 and older, any sex, with Renal Cell Cancer Metastatic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this multicenter observational study is to elucidate the clinical and immunological characteristics of the abscopal effect in patients with metastatic renal cell carcinoma (mRCC) receiving immune checkpoint inhibitors (ICI) combined with image-guided ultra-hypofractionated radiotherapy (IGU). The main questions this study aims to answer are: What is the abscopal response rate (ARR) at one year after IGU in patients continuing ICI treatment? What clinical and immunological factors are associated with the occurrence and timing of the abscopal effect? Participants are patients with mRCC who have experienced immune-confirmed stable or progressive disease during ICI therapy and are scheduled to receive IGU to a selected lesion. Researchers will observe tumor responses at irradiated and non-irradiated sites using standard imaging (CT/MRI) and collect clinical and laboratory data at baseline, 3, 6, 9, and 12 months after IGU. Optional exploratory blood samples will be obtained for cytokine analysis (e.g., IFN-β, IFN-γ, TNF-α, IL-6). The primary outcome is the abscopal response rate (ARR) at one year after IGU. Secondary outcomes include tumor shrinkage rate of irradiated and non-irradiated lesions, 1-year overall survival, disease-specific survival, and progression-free survival. This study seeks to establish a foundation for developing combined immunotherapy and ultra-hypofractionated radiotherapy strategies for metastatic renal cell carcinoma. \*This study is led by Prof. Hiroshi Onishi (University of Yamanashi). The registry entry is managed by Dr. Zhe Chen on behalf of the study group.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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