[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650250":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":21,"centralContacts":27,"locations":37,"responsibleParty":54,"collaborators":21,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":21,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":21,"enrollmentInfo":65,"targetDuration":21,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":21,"overallStatus":40,"whyStopped":21,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Hebei Medical University Fourth Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"SABR + Axitinib + Toripalimab","EXPERIMENTAL","All participants receive stereotactic ablative radiotherapy (SABR) to all measurable metastatic lesions (≥7 Gy per fraction, 5 fractions, BED₃ ≥ 115 Gy), concurrent axitinib (5 mg orally twice daily) and toripalimab (240 mg intravenously every 3 weeks for up to 35 cycles). Axitinib is continued until disease progression, intolerable toxicity, or withdrawal of consent. For oligoprogressive lesions (≤5 lesions), additional SABR may be administered at the investigator's discretion.",[13,14],"Drug: axitinib plus toripalimab","Radiation: SABR",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","axitinib plus toripalimab","Axitinib 5 mg administered orally twice daily continuously, combined with toripalimab 240 mg administered intravenously every 3 weeks for up to 35 cycles (approximately 2 years).",[9],null,{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":21},"RADIATION","SABR","All participants receive stereotactic ablative radiotherapy (SABR) to all measurable metastatic lesions, delivering ≥7 Gy per fraction in 5 fractions, achieving a biologically equivalent dose (BED₃) ≥ 115 Gy based on α\u002Fβ = 3 Gy. For lesions adjacent to organs at risk, partial-SABR is permitted. If SABR or partial-SABR is infeasible, moderately hypofractionated radiotherapy (MHFRT) with curative intent may be substituted at the discretion of the radiation oncologist.",[9],[28,33],{"name":29,"role":30,"phone":31,"phoneExt":21,"email":32},"Linlin Xiao, Dr","CONTACT","18533167355","drxiaolinlin@163.com",{"name":34,"role":30,"phone":35,"phoneExt":21,"email":36},"Fengpeng Wu","15032818011","wfpzhj@126.com",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"the Fourth Hospital of Hebei Medical University","RECRUITING","Shijiazhuang","Hebei","050011","China","CN",{"type":47,"coordinates":48},"Point",[49,50],114.47861,38.04139,{"lat":50,"lon":49},[53],{"name":34,"role":30,"phone":35,"phoneExt":21,"email":36},{"type":55,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100650250","phase-2-sabr-combined-with-axitinib-and-toripalimab-for-oligometastatic-renal-cell-carcinoma-100650250",false,"NCT07744932","SABR Combined With Axitinib and Toripalimab for Oligometastatic Renal Cell Carcinoma","A Prospective, Single-Center, Single-Arm, Phase II Clinical Study of Stereotactic Ablative Radiotherapy Combined With Axitinib and Toripalimab in the Treatment of Oligometastatic Clear Cell Renal Cell Carcinoma","Inclusion Criteria:\n\nHistologically confirmed diagnosis of clear cell renal cell carcinoma (ccRCC).\n\nAge ≥ 18 years.\n\nEastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n\nRadiological evidence of distant metastasis meeting the MD Anderson (MDA) definition of oligometastatic disease: ≤5 metastatic lesions, all amenable to curative-intent local therapy. Lesions must be measurable per RECIST 1.1 criteria.\n\nPrior definitive local therapy to the primary tumor, including surgery, stereotactic radiotherapy, or ablation.\n\nEither no prior systemic therapy for metastatic disease (first-line naïve), or prior first-line tyrosine kinase inhibitor (TKI) therapy only with subsequent oligoprogression (≤5 progressive lesions with remaining lesions stable).\n\nAdequate organ function:\n\nHemoglobin (Hb) ≥ 80 g\u002FL\n\nAbsolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL\n\nPlatelet count (PLT) ≥ 75 × 10⁹\u002FL\n\nSerum total bilirubin ≤ 1.5 × upper limit of normal (ULN)\n\nAlanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN\n\nProthrombin time (PT) and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN\n\nVoluntary written informed consent obtained, with commitment to complete all treatment and follow-up visits.\n\nExclusion Criteria:\n\nTarget lesions previously treated with radiotherapy with a biologically effective dose (BED₃) ≥ 60 Gy (calculated with α\u002Fβ = 3 Gy).\n\nTarget lesions deemed unsuitable for radiotherapy by the treating radiation oncologist (e.g., lesions invading the gastrointestinal tract or penetrating the bronchus).\n\nUncontrolled malignant pleural effusion or ascites.\n\nPresence of other uncured malignancies.\n\nHistory of severe psychiatric illness interfering with understanding of informed consent or compliance with study procedures.\n\nSevere cardiovascular disease: New York Heart Association (NYHA) class III-IV heart failure, uncontrolled arrhythmia, or myocardial infarction within the past 6 months.\n\nAny other serious medical condition that, in the investigator's judgment, may pose significant risk or interfere with radiotherapy.\n\nPregnancy, breastfeeding, or planned pregnancy during the study period.\n\nAny other reason determined by the investigator that makes the participant unsuitable for study participation.","ALL","18 Years",{"count":66,"type":67},48,"ESTIMATED","INTERVENTIONAL",[70],"PHASE2","This is a phase II clinical trial testing whether a combination of stereotactic ablative radiotherapy (SABR), axitinib, and toripalimab is effective and safe for treating oligometastatic clear cell renal cell carcinoma (a type of kidney cancer that has spread to 5 or fewer sites).\n\nIn this study, all metastatic tumors will be treated with SABR - a precise, high-dose radiation therapy delivered in 5 sessions. At the same time, participants will receive axitinib (an oral targeted cancer drug) twice daily, and toripalimab (an intravenous immunotherapy) every 3 weeks for up to 2 years.\n\nThe study will enroll 48 participants. The main goal is to measure the objective response rate - the proportion of patients whose tumors shrink or disappear after treatment. Researchers will also track how long patients live without their cancer worsening, overall survival, and any side effects from the treatment.\n\nParticipants will have regular imaging scans, blood tests, and quality-of-life assessments throughout the treatment and follow-up period.",[73],"Oligometastatic Clear Cell Renal Cell Carcinoma","2026-07-30",{"date":76,"type":77},"2026-08-04","ACTUAL",{"date":79,"type":67},"2026-08-15",{"date":81,"type":67},"2029-12-30",{"name":5,"class":6},1]