Actively Recruiting
Observational Study on the Abscopal Effect by Ultra-Hypofractionated Radiation Therapy Combined With Immune Checkpoint Inhibitors for Metastatic Renal Cell Carcinoma
Led by Zhe Chen · Updated on 2025-12-05
145
Participants Needed
1
Research Sites
78 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
This research aims to understand the abscopal effect in patients with metastatic renal cell carcinoma (mRCC) who are receiving immune checkpoint inhibitors (ICIs) combined with image-guided ultra-hypofractionated radiotherapy (IGU). The study focuses on measuring the abscopal response rate (ARR) one year after IGU and identifying clinical and immunological factors linked to this effect. It is a multicenter observational study conducted from 2025 to 2028, led by Prof. Hiroshi Onishi and managed by Dr. Zhe Chen. Participants receive IGU using stereotactic or similar ultra-hypofractionated radiotherapy techniques, typically delivering 24-30 Gy in 1-3 fractions to selected metastatic lesions, following institutional standards. Patients continue their ICI therapy as determined by their oncologist. There is no randomization or additional treatment beyond standard care. The study includes a one-year follow-up period with imaging assessments and optional blood samples for cytokine analysis. During the study, tumor responses at irradiated and non-irradiated sites are evaluated using CT or MRI at baseline and at 3, 6, 9, and 12 months post-IGU. Clinical status, laboratory tests, and toxicity are monitored throughout. Researchers measure the abscopal response rate at one year, tumor shrinkage rates, overall survival, disease-specific survival, and progression-free survival. Blood samples may be collected to explore immune biomarkers. Data is recorded electronically, and participants are followed for one year to assess outcomes.
CONDITIONS
Brief 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
- Currently receiving immune checkpoint inhibitor therapy with immune-confirmed stable or progressive disease
- Have two or more clinically measurable lesions assessed by CT, MRI, physical exam, or visual inspection (excluding osteosclerotic lesions without soft-tissue components)
- Planned to undergo image-guided ultra-hypofractionated radiotherapy (IGU) to the target lesion
- Provided written informed consent (proxy signature allowed if patient cannot sign)
You will not qualify if you...
- Active double cancers within 2 years, except certain early-stage or treated cancers and those with disease-free interval over 2 years
- Serious comorbidities including severe heart disease, uncontrolled diabetes despite insulin, recent myocardial infarction, uncontrolled hypertension, active infections, bowel obstruction, autoimmune disease, or other severe conditions
- Clear evidence of idiopathic interstitial pneumonia on chest imaging
- Acute-phase pneumonia
- Psychiatric disorders or symptoms that make study participation difficult
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Typically 1 to 3 treatment fractions over a few days
Participants undergo image-guided ultra-hypofractionated radiotherapy (IGU) targeting metastatic lesions while continuing immune checkpoint inhibitor therapy as part of standard clinical care.
1 to 3 treatment visits (in-person)
Duration - 12 months
Participants are monitored with imaging assessments and clinical evaluations to observe tumor response, survival outcomes, and immune biomarkers for up to one year after IGU.
Imaging and clinical visits at baseline, and at 3, 6, 9, and 12 months post-IGU
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
H
Hiroshi Onishi, MD, PhD
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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