{
  "abstract": "Introduction Patients with metastatic renal cell carcinoma (mRCC) treated with immune checkpoint inhibitors (ICIs) may experience immune-confirmed stable disease (iSD) or progressive disease (iCPD). Abscopal responses following ultra-hypofractionated radiotherapy during immunotherapy have been reported, but their incidence, timing and associated clinical or biological factors remain poorly defined in prospective observational settings.Methods and analysis AURICRE is a prospective, multicentre observational study that plans to enrol 145 patients with mRCC who exhibit iSD or iCPD during ongoing ICI therapy. Participants undergo stereotactic ablative radiotherapy (SABR) to either the primary tumour or selected metastatic lesions. Prespecified SABR regimens include 42 Gy in three fractions or 40 Gy in five fractions for primary tumours, and fractionated schedules delivering ≥5 Gy per fraction for metastatic sites, with metastatic site regimens corresponding to a BED 10 range of 40–85 Gy. The primary outcome is the abscopal response rate, defined as objective responses in non-irradiated lesions assessed using iRECIST. Secondary outcomes include tumour shrinkage rates and 1-year overall survival. Exploratory analyses will evaluate changes in circulating cytokines measured centrally before and after radiotherapy.Ethics and dissemination This study was approved by the Institutional Review Board of the University of Yamanashi (Approval Number: CS0075). Written informed consent will be obtained from all participants before provisional registration. Study findings will be disseminated through peer-reviewed publications and scientific meetings.Trial registration number This trial is registered at ClinicalTrials.gov ( NCT07240610) and the University Hospital Medical Information Network (UMIN000059652); Pre-results.",
  "authors": [
    {
      "affiliations": [
        "Department of Therapeutic Radiology, University of Yamanashi Faculty of Medicine, Chuo, Japan"
      ],
      "name": "Zhe Chen"
    },
    {
      "affiliations": [
        "Department of Therapeutic Radiology, University of Yamanashi Faculty of Medicine, Chuo, Japan"
      ],
      "name": "Hiroshi Onishi"
    },
    {
      "affiliations": [
        "Department of Urology, University of Yamanashi Faculty of Medicine, Chuo, Japan"
      ],
      "name": "Takahiko Mitsui"
    },
    {
      "affiliations": [
        "Department of Immunology, University of Yamanashi Faculty of Medicine, Chuo, Japan"
      ],
      "name": "Atsuhito Nakao"
    },
    {
      "affiliations": [
        "Department of Epidemiology, University of Yamanashi Faculty of Medicine, Chuo, Japan"
      ],
      "name": "Hiroshi Yokomichi"
    },
    {
      "affiliations": [
        "Clinical Trial Management Office, University of Yamanashi, Chuo, Japan"
      ],
      "name": "Mayumi Tsukahara"
    },
    {
      "affiliations": [
        "Clinical Trial Management Office, University of Yamanashi, Chuo, Japan"
      ],
      "name": "Shuichi Mochizuki"
    },
    {
      "affiliations": [
        "Department of Therapeutic Radiology, University of Yamanashi Faculty of Medicine, Chuo, Japan"
      ],
      "name": "Kan Marino"
    },
    {
      "affiliations": [
        "Department of Therapeutic Radiology, University of Yamanashi Faculty of Medicine, Chuo, Japan"
      ],
      "name": "Takafumi Komiyama"
    }
  ],
  "title": "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",
  "uid": "a4139341-351f-545a-8a07-7f0bab409dcf"
}