[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100496014":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":37,"locations":43,"responsibleParty":133,"collaborators":137,"id":141,"slug":142,"hasResults":143,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":31,"eligibilityCriteria":147,"healthyVolunteers":143,"sex":148,"minAge":149,"maxAge":150,"enrollmentInfo":151,"targetDuration":31,"studyType":154,"phases":155,"briefSummary":157,"conditions":158,"keywords":31,"overallStatus":46,"whyStopped":31,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":170},{"fullName":5,"class":6},"Sun Yat-sen University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Neoadjuvant group","EXPERIMENTAL","Neoadjuvant group will be given the neoadjuvant combination of axitinib plus Toripalimab + nephrectomy",[13,14],"Drug: Axitinib plus Toripalimab","Procedure: nephrectomy",{"label":16,"type":17,"description":18,"interventionNames":19},"Control group","ACTIVE_COMPARATOR","The control group will be given nephrectomy alone.",[14],[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Axitinib plus Toripalimab","Preoperative treatment with axitinib will be given for 3 months, 5 mg twice daily, orally. Preoperative treatment with Toripalimab will be given for 4 cycles (3 weeks considered one cycle), 240 mg, Q3W.",[9],[27],"nephrectomy",{"type":29,"name":27,"description":27,"armGroupLabels":30,"otherNames":31},"PROCEDURE",[16,9],null,[33],{"name":34,"affiliation":35,"role":36},"Fangjian Zhou, Professor","Director of Dept. of Urology, Sun Yat-sen University Cancer Center","PRINCIPAL_INVESTIGATOR",[38],{"name":39,"role":40,"phone":41,"phoneExt":31,"email":42},"Zhiling Zhang, Professor","CONTACT","+86-020-87343860","zhangzhl@sysucc.org.cn",[44,59,67,78,89,100,111,122],{"facility":45,"status":46,"city":47,"state":31,"zip":31,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Cancer Hospital Chinese Academy of Medical Sciences","RECRUITING","Beijing","China","CN",{"type":51,"coordinates":52},"Point",[53,54],116.39723,39.9075,{"lat":54,"lon":53},[57],{"name":58,"role":40,"phone":31,"phoneExt":31,"email":31},"Sujun Han, Dr",{"facility":60,"status":46,"city":47,"state":31,"zip":31,"country":48,"countryCode":49,"cosmosGeoPoint":61,"geoPoint":63,"contacts":64},"Peking University First Hospital",{"type":51,"coordinates":62},[53,54],{"lat":54,"lon":53},[65],{"name":66,"role":40,"phone":31,"phoneExt":31,"email":31},"Zhisong He, Dr",{"facility":68,"status":46,"city":69,"state":31,"zip":31,"country":48,"countryCode":49,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"Sun Yat-sen University Cancer Center","Guangzhou",{"type":51,"coordinates":71},[72,73],113.25,23.11667,{"lat":73,"lon":72},[76],{"name":77,"role":40,"phone":31,"phoneExt":31,"email":31},"Zhiling Zhang, Dr",{"facility":79,"status":46,"city":80,"state":31,"zip":31,"country":48,"countryCode":49,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"Anhui Provincial Hospital","Hefei",{"type":51,"coordinates":82},[83,84],117.28083,31.86389,{"lat":84,"lon":83},[87],{"name":88,"role":40,"phone":31,"phoneExt":31,"email":31},"JUn Xiao, Dr",{"facility":90,"status":46,"city":91,"state":31,"zip":31,"country":48,"countryCode":49,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"Fudan University Cancer Hospital","Shanghai",{"type":51,"coordinates":93},[94,95],121.45806,31.22222,{"lat":95,"lon":94},[98],{"name":99,"role":40,"phone":31,"phoneExt":31,"email":31},"Hailiang Zhang, Dr",{"facility":101,"status":46,"city":102,"state":31,"zip":31,"country":48,"countryCode":49,"cosmosGeoPoint":103,"geoPoint":107,"contacts":108},"West China Hospital","Sichuan",{"type":51,"coordinates":104},[105,106],105.48032,35.1221,{"lat":106,"lon":105},[109],{"name":110,"role":40,"phone":31,"phoneExt":31,"email":31},"Hao Zeng, Dr",{"facility":112,"status":46,"city":113,"state":31,"zip":31,"country":48,"countryCode":49,"cosmosGeoPoint":114,"geoPoint":118,"contacts":119},"Tianjin Medical University Cancer Institute and Hospital","Tianjin",{"type":51,"coordinates":115},[116,117],117.17667,39.14222,{"lat":117,"lon":116},[120],{"name":121,"role":40,"phone":31,"phoneExt":31,"email":31},"Yao Xin, Dr",{"facility":123,"status":46,"city":124,"state":31,"zip":31,"country":48,"countryCode":49,"cosmosGeoPoint":125,"geoPoint":129,"contacts":130},"The First Affiliated Hospital of Zhengzhou Hospital","Zhengzhou",{"type":51,"coordinates":126},[127,128],113.64861,34.75778,{"lat":128,"lon":127},[131],{"name":132,"role":40,"phone":31,"phoneExt":31,"email":31},"Xuepei Zhang, Dr",{"type":134,"investigatorFullName":135,"investigatorTitle":136,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"SPONSOR_INVESTIGATOR","ZHOU FANGJIAN","Professor",[138],{"name":139,"class":140},"Pfizer","INDUSTRY","100496014","phase-3-neoadjuvant-of-axitinib-plus-pd-1-to-improve-disease-free-survival-of-patients-with-renal-cell-carcinoma-100496014",false,"NCT05738694","Neoadjuvant of Axitinib Plus PD-1 to Improve Disease Free Survival of Patients With Renal Cell Carcinoma","A Multicenter Randomized Controlled Clinical Study of Neoadjuvant Combination of Axitinib Plus PD-1 Monoclonal Antibody to Improve Disease Free Survival of Patients With Renal Cell Carcinoma","Inclusion Criteria:\n\n1. Voluntarily agree to participate in this study and sign the informed consent form;\n2. Males or females between 18 years old and 80 years old;\n3. Diagnosed as clear cell carcinoma or renal cell carcinoma predominantly composed of clear cell carcinoma through histopathological examination\n4. CT or MRI clinical staging is T2G4 or T2 with sarcomatoid differentiation, T3-4, N1;\n5. ECOG performance status: 0 or 1 point;\n6. Sufficient heart, bone marrow, liver, and kidney functions:\n\nCardiac function: Cardiac function class 0-2; Blood routine test: WBC≥3.5×10\\^9\u002FL, absolute neutrophil count ≥1.5×10\\^9\u002FL, PLT≥75.0×10\\^9\u002FL, HGB≥80g\u002FL; Liver function: Total bilirubin ≤1.5×upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN; Renal function: GFR ≥ 45 ml\u002Fmin.\n\nExclusion Criteria:\n\n1. With distant metastasis\n2. Severe liver and renal dysfunction, combined with other serious diseases;\n3. Serious cardiovascular disease, including any of the following: myocardial infarction or arteritis or venous thrombosis (such as pulmonary embolism) in the past 1 year;\n4. Severe\u002Funstable angina pectoris; uncontrolled hypertension;\n5. Class III or IV heart failure by New York Heart Association (NYHA) Functional Classification;\n6. Ventricular arrhythmia requiring drug treatment.","ALL","18 Years","80 Years",{"count":152,"type":153},298,"ESTIMATED","INTERVENTIONAL",[156],"PHASE3","The study included 298 RCC patients who were at high risk for recurrence after nephrectomy (T2G3-4 or T3-4 or N1). They were randomly divided to receive axitinib plus PD-1 + surgery or surgery alone at a ratio of 1:1, so as to determine the efficacy of the neoadjuvant combination of axitinib plus PD-1.",[159,160],"Renal Cell Carcinoma","Neoadjuvant","2026-03-15",{"date":163,"type":164},"2026-03-17","ACTUAL",{"date":166,"type":164},"2023-04-19",{"date":168,"type":153},"2027-12-31",{"name":135,"class":6},8]