Tokyo, Nov. 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059652) titled 'Observational study to evaluate the systemic effects of radiotherapy in patients with metastatic renal cell carcinoma receiving immunotherapy' on Nov. 10.

Study Type: Observational

Primary Sponsor: Institute - University of Yamanashi

Condition: Condition - Renal Cancer Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - To elucidate the clinical and immunological characteristics of the abscopal effect in metastatic renal cell carcinoma patients receiving immunotherapy, and to establish a foundation for combined immunotherapy and ultra-hypofractionated radiotherapy strategies. Basic objectives2 - Others

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key 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 Key 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 Target Size - 145

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 08 Month 03 Day Date of IRB - 2025 Year 10 Month 27 Day Anticipated trial start date - 2025 Year 11 Month 10 Day Last follow-up date - 2029 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068205

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