High‑dose targeted radiation plus immunotherapy to trigger abscopal responses in metastatic kidney cancer
Official title: Observational Study on the Abscopal Efect by Ultra-hypofractionated Radiation Therapyin Combination With Immune Checkpoint Inhibiters for Metastatic Renal Cell Carcinoma
Run by University of Yamanashi · NCT07240610 · Data updated 2026-11-12
This study will try adding focused, very‑high‑dose radiation to ongoing immunotherapy to see if untreated metastatic kidney tumors shrink in people whose cancer is stable or getting worse on immune therapy.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 145 (estimated) |
| Sponsor | University of Yamanashi Academic / other |
| Drugs / interventions | immunotherapy, nivolumab, ipilimumab, chemotherapy, Radiation |
| Locations | 1 site (Chūō, Yamanashi) |
| Status | Recruiting |
| Started | November 10, 2025 |
| Main results expected | March 31, 2028 |
| Study ends | September 30, 2029 |
| Registry record updated | December 5, 2025 |
| Trial ID | NCT07240610 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with metastatic renal cell carcinoma who are receiving immune checkpoint inhibitors, have immune‑confirmed stable disease or progression, have at least two measurable lesions, and are planned to receive image‑guided ultra‑hypofractionated radiotherapy to a target lesion.
✕Probably not a fit
Patients with only non‑measurable osteosclerotic bone lesions, those with active recent second cancers, people not on ICI, or those with rapidly widespread progression are unlikely to receive benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
AURICRE is a multicenter prospective observational study following patients with metastatic renal cell carcinoma who have immune‑confirmed stable disease or progression while on immune checkpoint inhibitors and who are scheduled for image‑guided ultra‑hypofractionated radiotherapy (IGU) to a selected lesion. Investigators will document tumor responses at irradiated and non‑irradiated sites using standard CT/MRI imaging at baseline and at 3, 6, 9, and 12 months after IGU, alongside clinical and laboratory data collection. Optional exploratory blood samples will be collected to study immune changes and potential biomarkers. The primary aim is to measure the one‑year abscopal response rate and identify clinical or immunological factors linked to the occurrence and timing of abscopal effects.
Why it matters
Potential benefit: If successful, this approach could cause shrinkage of tumors outside the irradiated site and help people stay on beneficial immunotherapy longer.
How similar studies have gone: Several case reports and small series have reported abscopal responses after high‑dose radiotherapy combined with immunotherapy, but robust prospective evidence is still limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients aged 18 years and above with metastatic renal cell carcinoma 2. Patients currently receiving immune checkpoint inhibitor (ICI) therapy who are assessed as having iCPD or iSD according to iRECIST 3. 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 4. Planned to undergo IGU to the target lesion 5. Provided written informed consent after receiving sufficient explanation of this study Note: Proxy signature is permitted if the patient is physically unable to sign Exclusion Criteria: 1. Patients with active double cancers (synchronous double cancers or metachronous double cancers with a disease-free interval within 2 years). However, carcinoma in situ or intramucosal carcinoma considered cured by treatment, and the following tumors even if within 2 years of disease-free interval are not excluded: gastric cancer stage 0-II (UICC), prostate cancer stage I-III, colorectal cancer stage 0-II, esophageal cancer stage 0-I, breast cancer stage 0-II, endometrial cancer stage I-II, cervical cancer stage 0-II, and thyroid cancer stage I-III. In addition, any cancer with a disease-free interval greater than 2 years is not excluded regardless of stage. 2. Patients with serious comorbidities, such as: * severe cardiac disease * uncontrolled diabetes mellitus despite continuous insulin therapy * myocardial infarction within 6 months * uncontrolled hypertension * active infections (bacterial, viral, or fungal) * diarrhea (watery stool), paralytic ileus, or bowel obstruction * autoimmune disease * any other severe comorbid condition 3. Patients with clear evidence of idiopathic interstitial pneumonia (usual interstitial pneumonia pattern) on chest X-ray or CT 4. Patients with acute-phase pneumonia 5. Patients with psychiatric disorders or psychiatric symptoms judged to make study participation difficult
Where it's running
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University of Yamanashi Hospital
Chūō, Yamanashi, Japan Recruiting
Study contacts
- Principal investigator: Hiroshi Onishi, MD, PhD — University of Yamanashi
- Study coordinator: Zhe Chen, MD, PhD
- Email: chenzhe@yamanashi.ac.jp
- Phone: +81-55-273-1111
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.