Abscopal Effect of Ultra-Hypofractionated Radiation Plus Immunotherapy in Metastatic Renal Cell Carcinoma

NCT07240610 | Recruiting DMC

• 3 other identifiers: CS0075UMIN000059652JP24K02397
• Study Type: observational
• Target: 145
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Renal Cell Cancer Metastatic

Keywords

Abscopal Effect; Ultra-Hypofractionated Radiotherapy; Immune Checkpoint Inhibitors; Metastatic Renal Cell Carcinoma; Immunoradiotherapy Combination

Outcome Measures

Primary Outcomes (1)

• Abscopal Response Rate (ARR) at 1 Year After IGU

  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.

  12 months after image-guided ultra-hypofractionated radiotherapy (IGU)

Secondary Outcomes (4)

• Tumor Shrinkage Rate of Irradiated and Non-Irradiated Lesions

  Baseline to 12 months after IGU

• One-Year Overall Survival (OS)

  12 months after IGU

• One-Year Disease-Specific Survival (DSS)

  12 months after IGU

• One-Year Progression-Free Survival (PFS)

  12 months after IGU

Other Outcomes (1)

• Temporal Changes and Correlation of Serum Cytokine Profiles With Abscopal Response

  Baseline to 12 months after IGU

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (≥18 years) with histologically confirmed metastatic renal cell carcinoma (mRCC) who are receiving ICIs and are candidates for IGU to one or more metastatic lesions. Eligible patients must have immune-confirmed stable disease or progression during ongoing ICI therapy. Enrollment will include patients treated at participating centers of the AURICRE multicenter registry.

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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
• Patients with clear evidence of idiopathic interstitial pneumonia (usual interstitial pneumonia pattern) on chest X-ray or CT
• Patients with acute-phase pneumonia
• Patients with psychiatric disorders or psychiatric symptoms judged to make study participation difficult

Sponsors & Collaborators

• Zhe Chen: lead
• Participating institutions of the AURICRE Study Group: collaborator

Study Sites (1)

University of Yamanashi Hospital

Chūō, Yamanashi, 409-3898, Japan

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral blood samples (serum and plasma) for cytokine analysis.

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Hiroshi Onishi, MD, PhD

  University of Yamanashi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhe Chen, MD, PhD

CONTACT

+81-55-273-1111; chenzhe@yamanashi.ac.jp

Hiroshi Onishi, MD, PhD

CONTACT

+81-55-273-1111; honishi@yamanashi.ac.jp

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: November 21, 2025
• Study Start: November 10, 2025
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): September 30, 2029
• Last Updated: December 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)