[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100391429":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":32,"locations":41,"responsibleParty":60,"collaborators":18,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":18,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":18,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":44,"whyStopped":18,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Cancer Hospital of Guangxi Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Toripalimab+CCRT","EXPERIMENTAL","Toripalimab 240mg, and Cisplatin 100mg\u002Fm2 (every three weeks),D1,D22,D43 of intensity modulated radiotherapy (IMRT), followed by Toripalimab 240mg every 3 weeks with a total of 9 cycles as adjuvant anti-PD-1 immunotherapy.\n\nIMRT: total dose 60-66Gy, 1.8-2.0Gy\u002Ff",[13],"Drug: Toripalimab",{"label":15,"type":16,"description":17,"interventionNames":18},"CCRT alone","NO_INTERVENTION","Cisplatin 100mg\u002Fm2(every three weeks),D1,D22,D43 of intensity modulated radiotherapy (IMRT).\n\nIMRT: total dose 60-66Gy, 1.8-2.0Gy\u002Ff",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Toripalimab","anti-PD-1 antibody",[9],[26],"JS001",[28],{"name":29,"affiliation":30,"role":31},"Song Qu, PhD","Principal Investigator","PRINCIPAL_INVESTIGATOR",[33,37],{"name":29,"role":34,"phone":35,"phoneExt":18,"email":36},"CONTACT","86-13607887386","daisyqs2002@163.com",{"name":38,"role":34,"phone":39,"phoneExt":18,"email":40},"Zhong-Guo Liang, Master","86-15878779785","liangzhongguo@gxmu.edu.cn",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Guangxi Medical University Cancer Hospital","RECRUITING","Nanning","Guangxi","530021","China","CN",{"type":51,"coordinates":52},"Point",[53,54],108.31667,22.81667,{"lat":54,"lon":53},[57],{"name":58,"role":34,"phone":59,"phoneExt":18,"email":40},"Zhong-Guo liang, PhD","+8615878779785",{"type":31,"investigatorFullName":61,"investigatorTitle":30,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Song Qu","100391429","phase-3-toripalimab-for-local-regional-recurrent-nasopharyngeal-carcinoma-100391429",false,"NCT04376866","Toripalimab for Local-regional Recurrent Nasopharyngeal Carcinoma","Toripalimab in Combination With Concurrent Chemoradiotherapy for Local-regional Recurrent Nasopharyngeal Carcinoma: a Phase 3, Multicentre, Randomised Controlled Trial","Inclusion Criteria:\n\n1. Patients with newly histologically confirmed recurrent nasopharyngeal carcinoma, or Two or more image examinations (MRI, and PET-CT) show the recurrent tumor\n2. staged as rT3-4N0-1M0或rT1-4N2-3M0 （according to the 8th AJCC edition）\n3. Satisfactory performance status: ECOG (Eastern Cooperative OncologyGroup) scale 0-1\n4. Neutrophil ≥ 1.5×109 \u002FL and PLT ≥4×109 \u002FL and HGB ≥90 g\u002FL\n5. With normal liver function test (ALT、AST ≤ 2.5×ULN, TBIL≤ 1.5×ULN)\n6. With normal renal function test ( creatinine clearance ≥60 ml\u002Fmin)\n7. sign an \"informed consent form\n8. Male and no pregnant female\n\nExclusion Criteria:\n\n1. Age older than 65, or younger than 18 years old\n2. Hepatitis B surface antigen (HBsAg) positive and HBV-DNA ≥200IU\u002Fml, or 1000cps\u002Fml.\n3. Patients with positive HCV antibody.\n4. Active, known or suspected autoimmune disease; Type I Diabetes, hypothyroidism those only need hormone replacement therapy, and skin disease (leukoderma, psoriasis, alopecia et al) who don't need systemic therapy can recruit.\n5. History of interstitial lung disease\n6. Equivalent dose more than prednisone 10mg\u002Fd or other immunosuppressive treatments within 28 days prior to signing the informed consent.\n7. Receive or will receive live vaccine within 30 days prior to signing the informed consent.\n8. Women of child-bearing potential who are pregnant or breastfeeding.\n9. Suffered from malignant tumors, except the carcinoma in situ, papillary thyroid carcinoma, or skin cancer (non- melanoma) within five years.\n10. Hypersensitivity to macromolecular protein, or to any component of triplezumab.\n11. HIV positive.\n12. Severe, uncontrolled medical conditions and infections.\n13. Other diseases which may influence the safety or compliance of the clinical trial, such as heart failure with symptom, unstable angina, myocardial infarction, active infections those need systemic therapy, mental illness, or their family and society factors.","ALL","18 Years","65 Years",{"count":73,"type":74},204,"ESTIMATED","INTERVENTIONAL",[77],"PHASE3","This is a phase 3, multicentre, randomised controlled trial to study the effectiveness and toxicity of PD-1 antibody Toripalimab combined with concurrent cisplatin chemoradiotherapy versus cisplatin concurrent chemoradiotherapy alone in treating patients with locoregionally recurrent nasopharyngeal carcinoma.",[80],"Recurrent Nasopharyngeal Carcinoma",[80,22,82],"Concurrent chemoradiotherapy","2021-07-18",{"date":85,"type":86},"2021-07-20","ACTUAL",{"date":88,"type":86},"2020-06-28",{"date":90,"type":74},"2028-04",{"name":5,"class":6},1]