[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"renal-cell-cancer-metastatic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:renal-cell-cancer-metastatic":36},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,50,92,123],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100550778","phase-1-this-is-a-phase-1-trial-of-zm008-an-anti-llt1-antibody-used-as-single-agent-followed-by-combination-treatment-with-toripalimab-in-patients-with-advanced-solid-tumors-100550778",false,"NCT06451497","This is a Phase 1 Trial of ZM008, an Anti-LLT1 Antibody, Used as Single Agent Followed by Combination Treatment With Toripalimab in Patients With Advanced Solid Tumors","Phase 1 Dose Escalation Trial of ZM008, an Anti-LLT1 Antibody, as Single Agent Followed by Combination With Toripalimab in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Adult patients aged 18 years and older, at the time of signing the informed consent form.\n2. Part 1: Patients with histologically confirmed diagnosis of advanced (locoregionally recurrent, not amenable to curative therapy) or metastatic solid tumors that have no standard therapeutic option with a proven clinical benefit or are intolerant to these therapies with the following selected tumor histologies: NSCLC, triple-negative breast cancer, head and neck squamous cell carcinoma, prostate cancer, colorectal cancer, pancreatic ductal adenocarcinoma, biliary tract cancer, high grade serous ovarian cancer, diffuse large B cell lymphoma, kidney cancer, or urothelial cancer. This selection corresponds to tumor histologies known to express higher LLT1 levels. Other tumor histologies can be enrolled only if approved by the sponsor after discussion with the investigator. Tumors should be progressing or deserving another anticancer treatment in the opinion of the investigator. Part 2: The same patient population as Part 1 although it will be enriched or modified based on the observed antitumor activity observed in Part 1. In case the patient population is modified to include patients with standard therapeutic alternatives, a substantial amendment will be issued.\n3. Patients with tumors with actionable mutations should have progressed to all approved targeted therapies or have them contraindicated.\n4. The patient has measurable disease with RECIST 1. 1 on computed tomography (CT), positron emission tomography (PET)\u002FCT, or magnetic resonance imaging (MRI) scan. Imaging tests outside the screening period are valid if performed not more than 3 weeks before consent signature and otherwise fulfill protocol criteria. Patients with non-measurable disease may be allowed in Part 1 only with the explicit approval of the trial Medical Monitor.\n5. The patient has Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1. Patients with renal cell carcinoma (RCC) to be allocated to a backfill cohort in Part 1 can have PS ≤2.\n6. The patient has adequate hematologic function as defined by:\n\n   1. Hemoglobin ≥9 g\u002FdL (whole or partial blood transfusions not allowed in the two previous weeks).\n   2. Absolute neutrophil count (ANC) ≥1.0 × 109\u002FL (growth factors like granulocyte colony-stimulating factor are not allowed in the two previous weeks).\n   3. Platelet count ≥75 × 109\u002FL (platelet transfusions are not allowed in the two previous weeks).\n7. The patient has adequate hepatic function as defined by:\n\n   1. Total bilirubin ≤1.5 times upper limit of normal (ULN).\n   2. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0 times ULN, (if liver metastases are present, then ≤5.0 times ULN is allowed).\n   3. The patient has adequate renal function as defined by: estimated creatinine clearance (CrCL) using the Cockcroft- Gault formula ≥30 mL\u002Fminute.\n8. Women of childbearing potential (WOCBP) and men with sexual partners who are WOCBP must consent to adhere to contraceptive requirements as detailed in the protocol from the day of the signature of the informed consent to at least 4 months after the last dose of trial treatment.\n9. Suitable venous access for safe drug administration and the trial-required drug concentration and pharmacodynamic sampling.\n10. Permission to access archival biopsy located at the treating site or elsewhere. Note: Archival tissue does not need to be checked before Cycle 1 Day 1. The most modern archival biopsy is requested. If no archival tissue is available, the patient can still be enrolled in the escalation phase but not in Part 2.\n11. Pretreatment fresh biopsy is highly encouraged in Part 1 dose escalation once BED has been achieved. In Part 2, fresh pre-treatment and on-treatment biopsies should be obtained unless biopsy is associated with significant risk or declined by the patient and per discussion with the sponsor medical monitor (or designee).\n\nExclusion criteria:\n\n1. Patients should have recovered from toxicity related to previous anticancer treatments (including surgery and radiation) to Grade 0\u002F1 or baseline (except alopecia and peripheral neuropathy). Patients with endocrinopathies should have the replacement treatment in stable dosing.\n2. The patient has a history of uncontrolled brain metastasis. Patients with brain metastases are allowed if they are previously treated with surgery, whole-brain radiation, or stereotactic radiosurgery and have new brain imaging confirming that brain metastasis are stable (without evidence of progression by imaging using the identical imaging modality for each assessment, either MRI or CT) and considered controlled with \\\u003C10 mg\u002Fday prednisone equivalent at the time of receiving the first dose of ZM008. For asymptomatic patients, screening brain imaging is not required.\n3. The patient has received extended field radiotherapy ≤4 weeks before the start of treatment (≤2 weeks for limited field radiation for palliation), and who has not recovered to Grade ≤1 or baseline from related side effects of such therapy (except for alopecia).\n4. The patient had an active infection requiring parenteral or oral antibiotics at the time of the first dose. Patients receiving oral antibiotics can be enrolled after discussion and approval of the trial Medical Monitor.\n5. The patient has evidence of serious uncontrolled medical disorder that, in the opinion of the investigator or Medical Monitor, makes it unwise for the patient to participate in the trial or that might jeopardize compliance with the protocol.\n6. The patient has a psychiatric illness\u002Fsocial circumstance that would limit compliance with trial requirements and substantially increase the risk of AEs or has compromised ability to provide written informed consent.\n7. The patient has clinical evidence of an active second invasive malignancy with the exception of stable prostate cancer on watchful waiting, in situ cervical cancer, in situ breast carcinoma or localized non-melanoma skin cancers.\n8. The patient has uncontrolled or significant cardiovascular disease defined as New York Heart Association classification III or IV.\n9. The patient has baseline QTc (using the Fridericia correction calculation) \\>470 msec in patients without pacemaker. Active autoimmune disease that is requiring systemic treatment (i.e., with use of disease modifying agents, corticosteroids at \\>10 mg\u002Fday of equivalent prednisone, or immunosuppressive drugs at any dose). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Participants with adrenal insufficiency on oral steroid replacement are allowed to participate in the study. Participants with controlled type I diabetes mellitus on stable insulin regimen are also eligible for the study. Participants with rheumatoid arthritis or psoriasis may be eligible if they have not experienced a flare in 2 years and do not require systemic therapy within the past year. Participants with vitiligo are also eligible.\n10. Use of therapeutic immunosuppressive medication (eg, prednisone dose of ≥ 10 mg\u002Fday or equivalent, tumor necrosis factor inhibitors at any dose) within 28 days prior to the first planned dose of study treatment. This does not include intranasal, intraocular, inhaled corticosteroids, topical and intra-articular joint injections, or physiologic replacement doses of systemic corticosteroids. Less than 10 mg prednisone per day or equivalent, short term, is allowed.\n11. For patients in the ZM008 monotherapy and combination arms: Patients who discontinued prior treatment with any immune checkpoint due to immune-related AEs, irrespective of grade, recovery, or need for continued steroid therapy. Also, patients without formal contraindication due to previous irAE are not eligible if the AE has not resolved to Grade 1 or better and\u002For still requires steroids (\\>10 mg of prednisone equivalent per day) for ongoing management.\n12. History of interstitial lung disease\u002Fnon-infectious pneumonitis, including immune-related pneumonitis of any Grade, radiation pneumonitis, active pulmonary tuberculosis, or evidence of active pneumonitis on screening chest CT scan. Participants with radiation therapy to the lung that is \\>30 Gy within 6 months of the first dose of treatment are excluded. Participants with active lung infections requiring treatment are also excluded.\n13. The patient has live vaccines reception within 30 days of enrollment.\n14. Known active hepatitis B or C.\n15. Patients positive for human immunodeficiency virus (HIV) can be enrolled only in Part 2 of the trial, but HIV-positive patients must meet the following criteria: a. have CD4+ T cell (CD4+) counts ≥350 cells\u002FμL. b. have not had an opportunistic infection within the past 12 months. Patients on prophylactic antimicrobials can be included in the trial. c. should be on established antiretroviral therapy for at least 4 weeks. d. have an HIV viral load of less than 400 copies\u002FmL prior to enrollment. e. known history of any other relevant congenital or acquired immunodeficiency other than HIV infection.\n16. Has known or suspected allergy to trial treatment, excipients, or related products.\n17. Prior allogeneic bone marrow transplantation or solid organ transplantation.\n18. Toripalimab cohort only: Any contraindication present in the toripalimab prescribing information.","ALL","18 Years",{"count":19,"type":20},100,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is a phase 1 dose escalation trial of ZM008, an anti-LLT1 antibody as a single agent followed by combination with Toripalimab in patients with advanced solid tumors who have exhausted all standard therapy available or are intolerant of the same.",[26,27,28,29,30,31,32,33,34,35,36],"Non Small Cell Lung Cancer","Head and Neck Squamous Cell Carcinoma","Pancreas Adenocarcinoma","Biliary Tract Cancer","Prostate Cancer","Urothelial Carcinoma","Colorectal Cancer","Triple Negative Breast Cancer","High Grade Ovarian Serous Adenocarcinoma","Diffuse Large B Cell Lymphoma","Renal Cell Cancer Metastatic","RECRUITING","2026-03-27",{"date":40,"type":41},"2026-04-02","ACTUAL",{"date":43,"type":41},"2024-05-22",{"date":45,"type":20},"2027-04",{"name":47,"class":48},"Zumutor Biologics Inc.","INDUSTRY",3,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":21,"phases":60,"briefSummary":62,"conditions":63,"keywords":69,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":91},"100608132","phase-3-phase-3-study-to-assess-safety-and-efficacy-of-177lu-tlx250-in-advanced-relapsed-or-recurrent-ccrcc-100608132","NCT07197580","Phase 3 Study to Assess Safety and Efficacy of 177Lu-TLX250 in Advanced Relapsed or Recurrent ccRCC","A Phase 3, Randomized, Multi-Center, Open-Label Study to Compare 177Lu-TLX250 (Lutetium (177Lu) Girentuximab Tetraxetan) With the Investigator's Choice of a Single Agent Therapy in Participants With Carbonic Anhydrase 9 (CAIX) Expressing, Advanced Relapsed or Recurrent Clear Cell Renal Cell Carcinoma (ccRCC)","LUTEON","Inclusion Criteria:\n\n* be aged ≥ 18 years.\n* have provided written informed consent, dated and signed by the participant prior to any study-specific procedure;\n* have relapsed or recurrent, locally advanced, or metastatic RCC with histologically or cytologically confirmed diagnosis of RCC with clear cell component per American Joint Committee on Cancer Staging Manual (Edge SB et al., 2017), with or without sarcomatoid features;\n* have received at least 2 and no more than 3 prior lines of systemic therapies for locally advanced or metastatic ccRCC including a PD-1\u002FPD-L1 inhibitor (at least 2 administrations) and a VEGF\u002FVEGFR-targeting agent (including TKI or mAb) in sequence or in combination;\n* have had radiographic disease progression occurring during or after the most recent line of therapy or intolerance to most recent line of therapy;\n* have at least one measurable lesion according to RECIST, version 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions;\n* be CAIX-positive at Screening defined as having at least 1 lesion with a tumor-lesion CAIX ratio of the maximum standardized uptake value (SUVmax) to liver mean standardized uptake value SUVmean) ≥ 1.5 as determined by BICR of 89Zr-TLX250 PET outcomes;\n* have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1;\n* have recovered from the AEs related to prior lines of therapy or returned to baseline with the exception of Grade 2 neurotoxicity. Ongoing, controlled AEs, such as hypothyroidism or hypertension, are permitted;\n* have adequate organ function, defined as:\n* Bone Marrow:\n\n  * leukocytes ≥ 3,000\u002FµL;\n  * absolute neutrophil count ≥ 1500\u002FµL (administration of granulocyte colony stimulating factor is not allowed within 4 weeks prior to the first administration of 177Lu-TLX250;\n  * platelets ≥ 100,000\u002FµL (platelet transfusion is not allowed within 4 weeks prior to the first administration of 177Lu-TLX250); and\n  * hemoglobin ≥ 9g\u002FdL (red blood cell transfusion is not allowed within 2 weeks prior to the first administration of 177Lu-TLX250).\n* Liver Function:\n\n  * total bilirubin ≤ 1.5 × the upper limit of normal (ULN). For patients with known Gilbert's Syndrome ≤ 3 × ULN is permitted; and\n  * alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN or ≤ 5.0 × ULN for participants with liver metastases.\n* Renal Function:\n\n  * creatinine clearance ≥ 40 mL\u002Fmin as measured by Cockroft-Gault formula or directly calculated by 24h urine;\n  * have negative pregnancy test for women of childbearing potential (serum); and\n\nExclusion Criteria:\n\n* have any of the following:\n\n  * visceral metastatic lesions that are ≥ 1 cm that have a CAIX TLR \\\u003C 1;\n  * lytic bone metastatic lesions with a soft tissue component of at least 1 cm with a TLR \\\u003C 1; and\u002For\n  * at least one metastatic lymph node lesion with short axis ≥ 2.5 cm with a TLR \\\u003C1;\n* received prior 177Lu-TLX250 therapy, any other radioligand therapy, or any prior CAIX-targeting therapy;\n* have any known hypersensitivity to compounds of similar chemical or biologic composition to girentuximab, DFO or DOTA linker, zirconium or lutetium, and\u002For any excipient in the study drug or radiographic contrast-agents;\n* has received G-CSF or erythropoietin within 4 weeks prior to laboratory evaluations at Screening;\n* be currently receiving or have received:\n\n  * any radionuclide within 10 half-lives of the radionuclide prior to 89Zr-TLX250 administration;\n  * any type of systemic anticancer therapy within 2 weeks before the first administration of 177Lu-TLX250;\n  * prior radiotherapy within 2 weeks prior to the first administration of 177Lu-TLX250 (must have recovered from all radiation-related toxicities and not currently require steroid treatment); and\u002For\n  * prior palliative radiation (≤2 weeks of radiotherapy) within 1-week of the first administration of 177Lu-TLX250 for non-central nervous system disease; NOTE: If the investigator feels that the patient is continuing to receive some clinical benefit from standard-of-care (SOC) therapy, the patient may continue SOC therapy up until 2 weeks prior to dosing with 177Lu-TLX250.\n* have known brain metastases, unless these have been treated and stabilized for at least 4 weeks prior to the first administration of 177Lu-TLX250; Note: Participants with a history of brain metastases must have either a head CT with contrast-or brain MRI performed at Screening to document stable disease prior to the first administration of 177LuTLX250.\n* Have experienced any major trauma including major surgery (such as abdominal\u002F cardiac\u002Fthoracic surgery) within 3 weeks of administration of the first administration of 177LuTLX250;\n* be pregnant or intend to become pregnant, breastfeed, or conceive a child during the study period and for at least 42 days after last administration of 89Zr-TLX250 or 6 months after last administration of 177Lu-TLX250, depending on which study drug is administered last to the respective participant;\n* Note: Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies (see Appendix 10.4).\n* be planning to breastfeed during the study period and for 28 days after last administration of 89ZrTLX250 or 75 days after last administration of 177Lu-TLX250, depending on which study drug is administered last to the respective participant;\n* have active and uncontrolled infections requiring systemic therapy or other severe concurrent disease, which, in the opinion of the investigator, would place the participant at undue risk or interfere with the study;\n* have a history of concurrent malignancy with a life expectancy of ≤ 2 years or requirement of systemic anti-cancer therapy or requirement of local therapy that would confound study results; however; participants with the following malignancies can be enrolled into the study:\n\n  * basal cell or squamous cell carcinoma of the skin;\n  * carcinoma in situ of the cervix, breast or bladder; and\u002For\n  * incidental histologic finding of prostate cancer;\n* have a serious, non-healing wound, ulcer, or bone fracture;\n* be unable to stay in the scanner bed with the arms resting out of the thoracic and abdominal fields (i.e., arms alongside the body or raised arm position) for the duration of the scan;\n* have not had resolution of clinically significant toxic effects of prior systemic cancer therapy, surgery, or radiotherapy to Grade ≤1 (except for laboratory parameters specified above, Grade 2 alopecia, and\u002For stable Grade 2 sensory neuropathy, according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0;\n* have inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis, etc.);\n* have a life expectancy shorter than 3 months;\n* have bleeding or thrombotic disorders or subjects at risk for severe hemorrhage;\n* have experienced any clinically significant bleeding, including hemoptysis or tumor bleeding within 2 weeks prior to the first administration of 177Lu-TLX250;\n* has evidence of a serious active or sub-clinical infection or angina pectoris (New York Heart Association \\[NYHA\\] Class III or IV), significantly prolonged QT interval or other serious illness(es) involving the cardiac, respiratory, central nervous system, renal, hepatic or hematological organ systems, that might impair the ability to complete this study or could interfere with determination of causality of any adverse effects experienced in this study, or which require treatment that could interact with study treatment; or\n* have any medical or other condition that in the opinion of the investigator(s) would preclude the subject's participation in a clinical study.",{"count":59,"type":20},40,[61],"PHASE3","Multicenter Phase 3 study of 177Lu-TLX250 in adult participants with CAIX-expressing advanced, relapsed or recurrent clear cell renal cell carcinoma (ccRCC). Part 1 will evaluate two dosing regimens to determine the recommended Phase 3 dose (RP3D). Part 2 will compare 177Lu-TLX250 with investigator's choice of monotherapy aligned with Australian standard-of-care.",[64,65,66,36,67,68],"ccRCC","Renal Cell Carcinoma (Kidney Cancer)","Renal Cell Carcinoma (RCC)","Renal Cell Cancer, Recurrent","Clear Cell Renal Cell Cancer (ccRCC)",[70,71,72,64,73,74,75,76,77,78,79,80,81],"Carbonic anhydrase 9","Clear Cell Renal Cell Cancer","Kidney Cancer","CA9","CA-9","CAIX","Girentuximab","CA9 target therapy","Positron-Emission Tomography","Radiation Therapy","Radiopharmaceuticals","Targeted Radiation","2026-03-26",{"date":84,"type":41},"2026-04-01",{"date":86,"type":41},"2026-03-25",{"date":88,"type":20},"2029-02-28",{"name":90,"class":48},"Telix Pharmaceuticals (Innovations) Pty Limited",5,{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":100,"targetDuration":102,"studyType":103,"phases":4,"briefSummary":104,"conditions":105,"keywords":106,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":122},"100611440","abscopal-effect-of-ultra-hypofractionated-radiation-plus-immunotherapy-in-metastatic-renal-cell-carcinoma-100611440","NCT07240610","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","AURICRE","Inclusion Criteria:\n\n1. Patients aged 18 years and above with metastatic renal cell carcinoma\n2. Patients currently receiving immune checkpoint inhibitor (ICI) therapy who are assessed as having iCPD or iSD according to iRECIST\n3. 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\n4. Planned to undergo IGU to the target lesion\n5. Provided written informed consent after receiving sufficient explanation of this study Note: Proxy signature is permitted if the patient is physically unable to sign\n\nExclusion Criteria:\n\n1. Patients with active double cancers (synchronous double cancers or metachronous double cancers with a disease-free interval within 2 years).\n\n   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.\n2. Patients with serious comorbidities, such as:\n\n   * severe cardiac disease\n   * uncontrolled diabetes mellitus despite continuous insulin therapy\n   * myocardial infarction within 6 months\n   * uncontrolled hypertension\n   * active infections (bacterial, viral, or fungal)\n   * diarrhea (watery stool), paralytic ileus, or bowel obstruction\n   * autoimmune disease\n   * any other severe comorbid condition\n3. Patients with clear evidence of idiopathic interstitial pneumonia (usual interstitial pneumonia pattern) on chest X-ray or CT\n4. Patients with acute-phase pneumonia\n5. Patients with psychiatric disorders or psychiatric symptoms judged to make study participation difficult",{"count":101,"type":20},145,"1 Year","OBSERVATIONAL","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).\n\nThe main questions this study aims to answer are:\n\nWhat is the abscopal response rate (ARR) at one year after IGU in patients continuing ICI treatment?\n\nWhat clinical and immunological factors are associated with the occurrence and timing of the abscopal effect?\n\nParticipants 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\u002FMRI) 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).\n\nThe 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.\n\nThis study seeks to establish a foundation for developing combined immunotherapy and ultra-hypofractionated radiotherapy strategies for metastatic renal cell carcinoma.\n\n\\*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.",[36],[107,108,109,110,111],"Abscopal Effect","Ultra-Hypofractionated Radiotherapy","Immune Checkpoint Inhibitors","Metastatic Renal Cell Carcinoma","Immunoradiotherapy Combination","2025-11-30",{"date":114,"type":41},"2025-12-05",{"date":116,"type":41},"2025-11-10",{"date":118,"type":20},"2029-09-30",{"name":120,"class":121},"Zhe Chen","OTHER",1,{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":129,"eligibilityCriteria":130,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":131,"targetDuration":133,"studyType":103,"phases":4,"briefSummary":134,"conditions":135,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":147},"100464355","national-prospective-infrastructure-for-renal-cell-carcinoma-pro-rcc-100464355","NCT05326620","National PROspective Infrastructure for Renal Cell Carcinoma (PRO-RCC)","PROspective Renal Cancer Cohort (PRO-RCC)","PRO-RCC","Inclusion Criteria:\n\n* newly diagnosed patients with RCC or synchronous metastatic RCC\n* metachronous metastasized RCC\n* age \\>18 years\n* capable of understanding Dutch language\n\nExclusion Criteria:\n\n* n\u002Fa",{"count":132,"type":20},2000,"5 Years","PRO-RCC is a nationwide long-term cohort for the collection of real-world clinical data, patient reported outcome measures (PROMs) and patient reported experience measures (PREMs) that provides an infrastructure for observational research and (randomized) interventional studies with the TwiCs (Trial within cohorts) design.",[136,137,36],"Renal Cancer","Renal Cell Carcinoma","2025-06-03",{"date":140,"type":41},"2025-06-06",{"date":142,"type":41},"2023-01-19",{"date":144,"type":20},"2030-01",{"name":146,"class":121},"PROspective Renal Cancer Cohort Foundation",27]