[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629145":3},{"organization":4,"outcomesModule":7,"designInfo":32,"detailedDescription":11,"studyPopulation":11,"armGroups":38,"interventions":47,"overallOfficials":62,"centralContacts":66,"locations":76,"responsibleParty":97,"collaborators":11,"id":99,"slug":11,"hasResults":100,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":11,"eligibilityCriteria":104,"healthyVolunteers":100,"sex":105,"minAge":106,"maxAge":107,"enrollmentInfo":108,"targetDuration":11,"studyType":111,"phases":112,"briefSummary":114,"conditions":115,"keywords":11,"overallStatus":117,"whyStopped":11,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"Fujian Cancer Hospital","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Objective Response Rate (ORR)",null,"Assessed at baseline, before the second\u002Ffourth cycle of targeted-immunotherapy and at regular intervals during consolidation therapy follow-up throughout the study, from enrollment to 36 month.",[14,17,20,23,26,29],{"measure":15,"description":11,"timeFrame":16},"Progression-Free Survival (PFS)","From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months",{"measure":18,"description":11,"timeFrame":19},"Disease Control Rate (DCR)","Assessed at baseline, before the second\u002Ffourth cycle of targeted-immunotherapy and regular follow-up during consolidation therapy, from enrollment to 36 month.",{"measure":21,"description":11,"timeFrame":22},"Overall Survival (OS)","Followed up for the entire study period until patient death or study conclusion, from enrollment to 36 month.",{"measure":24,"description":11,"timeFrame":25},"Objective Response Rate in the Field of Irradiation","Assessed at baseline, post-SBRT (before the 2nd cycle of targeted-immunotherapy) and regular follow-up during consolidation therapy, from enrollment to 36 month..",{"measure":27,"description":11,"timeFrame":28},"Objective response rate (ORR) of irradiated versus non-irradiated lesions assessed by RECIST v1.1","Baseline, before cycle 2 and cycle 4 of immunotherapy (each cycle is 21 days), and up to 36 months.",{"measure":30,"description":11,"timeFrame":31},"Incidence of treatment-related adverse events (TRAEs) assessed by CTCAE v5.0","From baseline through study treatment period, up to 2 years.",{"allocation":33,"interventionModel":34,"interventionModelDescription":11,"primaryPurpose":35,"observationalModel":11,"timePerspective":11,"maskingInfo":36},"NA","SINGLE_GROUP","TREATMENT",{"masking":37,"maskingDescription":11,"whoMasked":11},"NONE",[39],{"label":40,"type":41,"description":42,"interventionNames":43},"SBRT combined with Anlotinib and Bemarituzumab","EXPERIMENTAL","Interventions:\n\n1. Radiation: stereotactic body radiotherapy (SBRT)\n2. Drug: Anlotinib\n3. Drug: Bemarituzumab",[44,45,46],"Radiation: Stereotactic Body Radiation Therapy (SBRT)","Drug: Anlotinib","Drug: Bemarituzumab",[48,53,58],{"type":49,"name":50,"description":51,"armGroupLabels":52,"otherNames":11},"RADIATION","Stereotactic Body Radiation Therapy (SBRT)","Dose fractionation: 39-48Gy\u002F3f or 40-50Gy\u002F5f, alternative 20-50Gy\u002F5f if OAR dose-limited. Dose adjusted per radiation toxicities during treatment.",[40],{"type":54,"name":55,"description":56,"armGroupLabels":57,"otherNames":11},"DRUG","Anlotinib","Oral anti-angiogenic agent, 12 mg qd fasting, 21d\u002Fcycle (2w on\u002F1w off)",[40],{"type":54,"name":59,"description":60,"armGroupLabels":61,"otherNames":11},"Bemarituzumab","Intravenous PD-1 inhibitor, 1200 mg q3w, 60min infusion",[40],[63],{"name":64,"affiliation":5,"role":65},"Jiunluan Li, MD","PRINCIPAL_INVESTIGATOR",[67,72],{"name":68,"role":69,"phone":70,"phoneExt":11,"email":71},"Jinluan Li, MD","CONTACT","+86-15159628678","lijinluan@fjmu.edu.cn",{"name":73,"role":69,"phone":74,"phoneExt":11,"email":75},"Shushang Chen, MD","+86-18960939103","121257401@qq.com",[77],{"facility":5,"status":11,"city":78,"state":79,"zip":80,"country":81,"countryCode":82,"cosmosGeoPoint":83,"geoPoint":88,"contacts":89},"Fuzhou","Fujian","350014","China","CN",{"type":84,"coordinates":85},"Point",[86,87],119.30611,26.06139,{"lat":87,"lon":86},[90,93,95,96],{"name":68,"role":69,"phone":91,"phoneExt":11,"email":92},"+86-15959628678","lijinluan@fjmuedu.cn",{"name":94,"role":69,"phone":74,"phoneExt":11,"email":75},"Shushang Shu, MD",{"name":68,"role":65,"phone":11,"phoneExt":11,"email":11},{"name":73,"role":65,"phone":11,"phoneExt":11,"email":11},{"type":98,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100629145",false,"NCT07470840","SBRT Plus Anlotinib and Bimepolizumab in Locally Advanced or Metastatic Renal Cell Carcinoma","A Phase II Multicenter Study of Stereotactic Body Radiation Therapy (SBRT) Combined With Anlotinib and Bimepolizumab in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma","Inclusion Criteria:\n\n1. Aged 18 to 80 years, regardless of sex.\n2. Histologically or cytologically confirmed locally advanced\u002Fmetastatic renal cell carcinoma (RCC) inoperable\u002Frefused for surgery, or post-operative locally recurrent\u002Fmetastatic RCC; pathological types include clear cell carcinoma and papillary renal cell carcinoma.\n3. ECOG performance status 0 or 1.\n4. At least 50% of all evaluable metastatic lesions are eligible for stereotactic body radiation therapy (SBRT).\n5. No contraindications to radiotherapy, targeted therapy or immunotherapy.\n6. At least one radiologically measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.\n7. Capable and willing to comply with the study protocol including scheduled visits, treatment plan, laboratory tests and other study-related procedures during the study period.\n8. Signed written informed consent form.\n\nExclusion Criteria:\n\n1. With contraindications to targeted or immunotherapeutic drugs.\n2. A history of other malignant diseases in the recent 5 years, except for cured skin cancer and carcinoma in situ of the cervix.\n3. With active autoimmune diseases, organ transplantation, or other diseases requiring immunosuppressive therapy or long-term hormone therapy.\n4. Extensive diffuse metastasis with an expected survival of less than 3 months.\n5. A history of uncontrolled epilepsy, central nervous system diseases or mental disorders, whose clinical severity is judged by the investigator to potentially hinder the signing of the informed consent form or affect the patient's compliance with oral medication.\n6. With severe uncontrolled recurrent infections or other serious uncontrolled concomitant diseases.\n7. Allergic to any component of the study drugs.\n8. The subject's baseline blood routine and biochemical indicators do not meet the following criteria: hemoglobin ≥80g\u002FL; absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL; platelet ≥100×10⁹\u002FL; ALT and AST ≤2.5 times the upper limit of normal; serum total bilirubin \\\u003C1.5 times the upper limit of normal; serum creatinine \\\u003C2 times the upper limit of normal.","ALL","18 Years","80 Years",{"count":109,"type":110},27,"ESTIMATED","INTERVENTIONAL",[113],"PHASE2","To investigate the objective response rate (ORR) of stereotactic body radiotherapy (SBRT) combined with anlotinib and beromuzumab in locally advanced\u002Fmetastatic renal cell carcinoma.",[116],"Locally Advanced or Metastatic Renal Cell Carcinoma","NOT_YET_RECRUITING","2026-03-22",{"date":120,"type":121},"2026-03-24","ACTUAL",{"date":123,"type":110},"2027-02-01",{"date":125,"type":110},"2029-06-01",{"name":5,"class":6},1]