Clinical trial · Observational
Abscopal Effect of Ultra-Hypofractionated Radiation Plus Immunotherapy in Metastatic Renal Cell Carcinoma
Observational Study on the Abscopal Efect by Ultra-hypofractionated Radiation Therapyin Combination With Immune Checkpoint Inhibiters for Metastatic Renal Cell Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Renal Cell Cancer Metastatic | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- mRCC patients receiving ICIs and IGU
- description
- 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.
Primary outcomes (1)
- measure
- Abscopal Response Rate (ARR) at 1 Year After IGU
- timeFrame
- 12 months after image-guided ultra-hypofractionated radiotherapy (IGU)
- description
- The proportion of patients showing an abscopal response, defined as a ≥30% reduction in the sum of diameters of non-irradiated target lesions without new lesion appearance, evaluated according to RECIST 1.1 criteria. Tumor response will be assessed by radiological imaging (CT or MRI) at each follow-up visit and confirmed by central review.
Secondary outcomes (4)
- measure
- Tumor Shrinkage Rate of Irradiated and Non-Irradiated Lesions
- timeFrame
- Baseline to 12 months after IGU
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDChen Z, Onishi H, Mitsui T, Nakao A, Yokomichi H, Tsukahara M, Mochizuki S, Marino K, Komiyama T. Abscopal responses following stereotactic ablative radiotherapy during immune checkpoint inhibitor therapy in metastatic renal cell carcinoma: protocol for the prospective multicentre observational AURICRE study in Japan. BMJ Open. 2026 Jul 7;16(7):e118228. doi: 10.1136/bmjopen-2026-118228. PMID 42414009