Actively Recruiting
Abscopal Effect of Ultra-Hypofractionated Radiation Plus Immunotherapy in Metastatic Renal Cell Carcinoma
Led by Zhe Chen · Updated on 2025-12-05
145
Participants Needed
1
Research Sites
202 weeks
Total Duration
On this page
Sponsors
Z
Zhe Chen
Lead Sponsor
P
Participating institutions of the AURICRE Study Group
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Abscopal Effect of Ultra-Hypofractionated Radiation Plus Immunotherapy in Metastatic Renal Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years and above with metastatic renal cell carcinoma
- Patients currently receiving immune checkpoint inhibitor (ICI) therapy who are assessed as having immune-confirmed progressive or stable disease
- Presence of two or more clinically measurable lesions assessed by CT, MRI, physical exam, or visual inspection (osteosclerotic lesions without measurable soft-tissue components are excluded)
- Planned to undergo image-guided ultra-hypofractionated radiotherapy (IGU) to the target lesion
- Provided written informed consent after receiving sufficient explanation of the study (proxy signature allowed if patient cannot sign)
You will not qualify if you...
- Patients with active double cancers (either synchronous or within 2 years disease-free interval), except certain early-stage cancers considered cured or with longer disease-free intervals
- Patients with serious comorbidities such as severe cardiac disease, uncontrolled diabetes despite insulin, recent myocardial infarction (within 6 months), uncontrolled hypertension, active infections, diarrhea, paralytic ileus, bowel obstruction, autoimmune disease, or other severe conditions
- Patients with clear evidence of idiopathic interstitial pneumonia on chest X-ray or CT
- Patients with acute-phase pneumonia
- Patients with psychiatric disorders or symptoms that make study participation difficult
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Yamanashi Hospital
Chūō, Yamanashi, Japan, 409-3898
Actively Recruiting
Research Team
Z
Zhe Chen, MD, PhD
CONTACT
H
Hiroshi Onishi, MD, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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