Observational Study on the Abscopal Efect by Ultra-hypofractionated Radiation Therapyin Combination With Immune Checkpoint Inhibiters for Metastatic Renal Cell Carcinoma

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients aged 18 years and above with metastatic renal cell carcinoma

• Patients currently receiving immune checkpoint inhibitor (ICI) therapy who are assessed as having iCPD or iSD according to iRECIST

• Presence of two or more clinically measurable lesions (assessed by CT, MRI, physical examination, or visual inspection) Note: Osteosclerotic lesions without measurable soft-tissue components are excluded

• Planned to undergo IGU to the target lesion

• Provided written informed consent after receiving sufficient explanation of this study Note: Proxy signature is permitted if the patient is physically unable to sign

Locations
Other Locations
Japan
University of Yamanashi Hospital
RECRUITING
Chūō
Contact Information
Primary
Zhe Chen, MD, PhD
chenzhe@yamanashi.ac.jp
+81-55-273-1111
Backup
Hiroshi Onishi, MD, PhD
honishi@yamanashi.ac.jp
+81-55-273-1111
Time Frame
Start Date: 2025-11-10
Estimated Completion Date: 2029-09-30
Participants
Target number of participants: 145
Treatments
mRCC patients receiving ICIs and IGU
This cohort includes patients with histologically confirmed mRCC who are receiving ICIs and undergo IGU to a selected metastatic lesion as part of their standard clinical care. Patients are followed prospectively for one year to evaluate abscopal responses, survival outcomes, and immune-related biomarkers.
Related Therapeutic Areas
Sponsors
Collaborators: Participating institutions of the AURICRE Study Group
Leads: Zhe Chen

This content was sourced from clinicaltrials.gov

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