[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100584462":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":22,"centralContacts":22,"locations":32,"responsibleParty":52,"collaborators":22,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":22,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":22,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":22,"overallStatus":34,"whyStopped":22,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Peking University First Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Combination Therapy: SABR + Axitinib + Toripalimab","EXPERIMENTAL","Patients in this arm will receive a combination of Stereotactic Ablative Body Radiotherapy (SABR), Axitinib, and Toripalimab.\n\nSABR: Radiation dose of 6-10 Gy per fraction, administered in 5 fractions for peripheral lesions. For lesions near organs at risk, partial-SABR will be used. If neither SABR nor partial-SABR is feasible, moderate hypofractionated radiotherapy (MHFRT) with curative doses will be applied. Treatment duration is 1-5 weeks based on lesion location.\n\nAxitinib (oral, tablet): 5 mg twice daily for the study duration or until progression or intolerable side effects.\n\nToripalimab (intravenous infusion): 240 mg every 3 weeks for the study duration or until progression or unacceptable toxicity.\n\nTreatment continues until disease progression, adverse events requiring discontinuation, or other study termination criteria are met",[13,14,15],"Radiation: Stereotactic Ablative Body Radiotherapy (SABR)","Drug: TORIPALIMAB INJECTION(JS001 )","Drug: Axitinib (VEGF-TKI)",[17,23,28],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"RADIATION","Stereotactic Ablative Body Radiotherapy (SABR)","Radiation dose of 6-10 Gy per fraction, administered in 5 fractions for peripheral lesions. For lesions near organs at risk, partial-SABR will be used. If neither SABR nor partial-SABR is feasible, moderate hypofractionated radiotherapy (MHFRT) with curative doses will be applied.",[9],null,{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":22},"DRUG","TORIPALIMAB INJECTION(JS001 )","Toripalimab (intravenous infusion):\n\nDosage: 240 mg intravenously every 3 weeks. Frequency: Administered every 3 weeks for the duration of the study, until progression or unacceptable toxicity occurs or reach 2 years.",[9],{"type":24,"name":29,"description":30,"armGroupLabels":31,"otherNames":22},"Axitinib (VEGF-TKI)","Axitinib (oral, tablet):\n\nDosage: 5 mg orally twice daily. Frequency: Daily, for the duration of the study, with continuation during progression or until intolerable side effects occur.",[9],[33],{"facility":5,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"RECRUITING","Beijing","Beijing Municipality","100034","China","CN",{"type":41,"coordinates":42},"Point",[43,44],116.39723,39.9075,{"lat":44,"lon":43},[47],{"name":48,"role":49,"phone":50,"phoneExt":22,"email":51},"Mingwei Ma","CONTACT","+86-15810160120","dr.mingweima@stu.pku.edu.cn",{"type":53,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","100584462","phase-2-sabr-combined-with-axitinib-and-toripalimab-in-recurrent-or-metastatic-rcc-100584462",false,"NCT06889649","SABR Combined with Axitinib and Toripalimab in Recurrent or Metastatic RCC","Prospective Study on the Efficacy and Safety of Stereotactic Ablative Body Radiotherapy Combined with Axitinib and Toripalimab in Recurrent or Metastatic Renal Cell Carcinoma","Inclusion Criteria:\n\n1. Histopathologically confirmed renal cell carcinoma with recurrent metastatic lesions confirmed by PET\u002FCT or other systemic imaging.\n2. Patients with ≤5 metastatic lesions amenable to complete lesion coverage radiotherapy; or \\>5 lesions with at least 3 suitable for radiotherapy as evaluated by the radiotherapy and imaging departments.\n3. Age between 18-80 years.\n4. Expected survival of ≥12 weeks.\n5. Measurable disease based on RECIST Version 1.1.\n6. ECOG performance status of 0-2.\n\nExclusion Criteria:\n\n1. History of anti-PD-1 or PD-L1 antibody therapy, or radiotherapy.\n2. Use of corticosteroids or other immunosuppressants within 14 days before treatment.\n3. Autoimmune diseases.\n4. History of other malignancies.\n5. History of surgery within 28 days before treatment.\n6. Allergy to study drug components.","ALL","18 Years","80 Years",{"count":65,"type":66},30,"ESTIMATED","INTERVENTIONAL",[69],"PHASE2","This is a prospective, single-center clinical trial designed to evaluate the safety and efficacy of combining stereotactic ablative body radiotherapy (SABR) with the targeted therapy Axitinib and the immunotherapy Toripalimab in patients with recurrent metastatic renal cell carcinoma (RCC). Patients will receive a treatment regimen consisting of Axitinib, Toripalimab, and comprehensive multi-lesion SABR. The primary endpoint is Progression-Free Survival 1 (PFS1), and secondary endpoints include Progression-Free Survival 2 (PFS2), Overall Survival (OS), Local Control (LC), Objective Response Rate (ORR), and Disease Control Rate (DCR). Adverse events will be monitored according to the Common Terminology Criteria for Adverse Events (CTCAE 5.0). The aim of this study is to explore a potentially more effective treatment combination for recurrent metastatic RCC.",[72,73,74,75],"Radiation Therapy","Targeted Therapy","Immunotherapy","Renal Cancer Metastatic","2025-03-19",{"date":78,"type":79},"2025-03-21","ACTUAL",{"date":81,"type":79},"2019-01-01",{"date":83,"type":66},"2028-02-20",{"name":5,"class":6},1]