[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100422294":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":38,"locations":47,"responsibleParty":137,"collaborators":140,"id":152,"slug":153,"hasResults":154,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":33,"eligibilityCriteria":158,"healthyVolunteers":154,"sex":159,"minAge":160,"maxAge":161,"enrollmentInfo":162,"targetDuration":33,"studyType":165,"phases":166,"briefSummary":168,"conditions":169,"keywords":173,"overallStatus":50,"whyStopped":33,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":183,"completionDateStruct":184,"leadSponsor":186,"locationsCount":187},{"fullName":5,"class":6},"Sun Yat-sen University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Toripalimab plus salvage surgery","EXPERIMENTAL","1. Toripalimab: Toripalimab treatment before and after salvage surgery.\n2. Salvage surgery: endoscopic nasopharyngectomy for recurrent nasopharyngeal tumor, and selective neck dissection for recurrent regional lymph node.",[13,14],"Drug: Toripalimab","Procedure: salvage surgery",{"label":16,"type":17,"description":18,"interventionNames":19},"Salvage surgery alone","ACTIVE_COMPARATOR","1\\. Salvage surgery: endoscopic nasopharyngectomy for recurrent nasopharyngeal tumor, and selective neck dissection for recurrent regional lymph node.",[14],[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Toripalimab","Toripalimab: 240 mg, intravenous injection over 60 minutes (Q3W); Toripalimab should be completed for 2 cycles at 1-2 weeks before surgery, and continually applied since 1-2 weeks after surgery until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, investigator decision, or 1 year.",[9],[27],"PD-1 antibody",{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"PROCEDURE","salvage surgery","Endoscopic nasopharyngectomy is used for recurrent nasopharyngeal tumor and selective neck dissection for recurrent regional lymph node.",[16,9],null,[35],{"name":36,"affiliation":5,"role":37},"Ming-Yuan Chen, MD, PhD","PRINCIPAL_INVESTIGATOR",[39,43],{"name":36,"role":40,"phone":41,"phoneExt":33,"email":42},"CONTACT","86-20-87343624","chmingy@mail.sysu.edu.cn",{"name":44,"role":40,"phone":45,"phoneExt":33,"email":46},"You-Ping Liu, MD, PhD","86-20-87343379","liuyoup@sysucc.org.cn",[48,65,77,88,99,110,124],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Sun Yat-sen University Cancer Center","RECRUITING","Guangzhou","Guangdong","510060","China","CN",{"type":57,"coordinates":58},"Point",[59,60],113.25,23.11667,{"lat":60,"lon":59},[63],{"name":36,"role":40,"phone":64,"phoneExt":33,"email":42},"86-20-8734-3624",{"facility":66,"status":67,"city":51,"state":52,"zip":68,"country":54,"countryCode":55,"cosmosGeoPoint":69,"geoPoint":71,"contacts":72},"The First Affiliated Hospital, Sun Yat-Sen University","NOT_YET_RECRUITING","510080",{"type":57,"coordinates":70},[59,60],{"lat":60,"lon":59},[73],{"name":74,"role":40,"phone":75,"phoneExt":33,"email":76},"Wei-Ping Wen, MD, PhD","86-13802966937","wenwp@mail.sysu.edu.cn",{"facility":78,"status":67,"city":51,"state":52,"zip":79,"country":54,"countryCode":55,"cosmosGeoPoint":80,"geoPoint":82,"contacts":83},"Nanfang Hospital of Southern Medical University","510515",{"type":57,"coordinates":81},[59,60],{"lat":60,"lon":59},[84],{"name":85,"role":40,"phone":86,"phoneExt":33,"email":87},"Hao-Cheng Tang, MD.PhD","86-15920115552","hctang2006@qq.com",{"facility":89,"status":67,"city":51,"state":52,"zip":90,"country":54,"countryCode":55,"cosmosGeoPoint":91,"geoPoint":93,"contacts":94},"The Fifth Affiliated Hospital of Guangzhou Medical University","510700",{"type":57,"coordinates":92},[59,60],{"lat":60,"lon":59},[95],{"name":96,"role":40,"phone":97,"phoneExt":33,"email":98},"Jian-Zhong Zhang, MD","86-15820279737","525567166@qq.com",{"facility":100,"status":67,"city":51,"state":52,"zip":101,"country":54,"countryCode":55,"cosmosGeoPoint":102,"geoPoint":104,"contacts":105},"The First People's Hospital of Foshan","528000",{"type":57,"coordinates":103},[59,60],{"lat":60,"lon":59},[106],{"name":107,"role":40,"phone":108,"phoneExt":33,"email":109},"Jun Tang, MD","86-18038860199","tjun@fsyyy.com",{"facility":111,"status":67,"city":112,"state":52,"zip":113,"country":54,"countryCode":55,"cosmosGeoPoint":114,"geoPoint":118,"contacts":119},"Zhongshan People's Hospital","Zhongshan","528403",{"type":57,"coordinates":115},[116,117],113.37912,22.52306,{"lat":117,"lon":116},[120],{"name":121,"role":40,"phone":122,"phoneExt":33,"email":123},"Min-Yi Fu","86-13924933366","503498362@qq.com",{"facility":125,"status":67,"city":126,"state":127,"zip":128,"country":54,"countryCode":55,"cosmosGeoPoint":129,"geoPoint":133,"contacts":134},"The Tenth Affiliated Hospital, Sun Yat-Sen University","Nanchang","Jiangxi","330008",{"type":57,"coordinates":130},[131,132],115.85306,28.68396,{"lat":132,"lon":131},[135],{"name":36,"role":40,"phone":136,"phoneExt":33,"email":42},"86-13903052650",{"type":37,"investigatorFullName":138,"investigatorTitle":139,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"Ming-Yuan Chen","Professor, Chief Doctor",[141,143,145,147,149],{"name":142,"class":6},"First Affiliated Hospital, Sun Yat-Sen University",{"name":144,"class":6},"Nanfang Hospital, Southern Medical University",{"name":146,"class":6},"First People's Hospital of Foshan",{"name":148,"class":6},"Zhongshan People's Hospital, Guangdong, China",{"name":150,"class":151},"Tenth Affiliated Hospital, Sun Yat-sen University","UNKNOWN","100422294","phase-3-toripalimab-plus-surgery-vs-surgery-alone-for-resectable-recurrent-nasopharyngeal-carcinoma-100422294",false,"NCT04778956","Toripalimab Plus Surgery vs Surgery Alone for Resectable Recurrent Nasopharyngeal Carcinoma","Toripalimab Plus Surgery vs Surgery Alone for Resectable Recurrent Nasopharyngeal Carcinoma: a Prospecitve, Parallel, Multicenter, Phase III, Randomized Clinical Trial","Inclusion Criteria:\n\n1. The recurrence time is more than 6 months from the end of radiotherapy.\n2. Histologically confirmed recurrent nasopharyngeal carcinoma.\n3. Resectable nasopharyngeal diseases: recurrent T1 (the tumor is confined in nasopharynx, oropharynx and\u002For nasal cavity without parapharyngeal involvement); recurrent T2 (the tumor is confined in the superficial parapharyngeal spacer and is more than 0.5cm far from the internal carotid artery) and recurrent T3 (the tumor is confined in the base wall of the sphenoid sinus and is more than 0.5cm far from the internal carotid artery and cavernous sinus). (according to the 8th edition of American Joint Committee on Cancer (AJCC) staging system for nasopharyngeal carcinoma)\n4. Resectable recurrent regional lymph node diseases (recurrent N1-3) without prevertebral fascia, cervical vertebrae, or common\u002Finternal carotid artery involvement. (according to the 8th edition of AJCC staging system)\n5. Given written informed consent.\n\nExclusion Criteria:\n\n1. Karnofsky Performance Status (KPS) ≤70.\n2. Has severe medical disorder, important organ dysfunction, and\u002For a substantial history of mental illness.\n3. Has known subjects with other malignant tumors.\n4. Has participated in other drug trials within 3 months of planned start of study treatment.\n5. Received a systematic or local glucocorticoid therapy within 4 weeks of planned start of study treatment.\n6. Suffered from diseases need long-term treatment with immunosuppressive drugs, or required systematic or local glucocorticoid therapy with immunosuppressive doses.\n7. Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) or cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) agent.\n8. Has active autoimmune disease (e.g., uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, and asthma requiring bronchodilator therapy). Patients with skin disease that doesn't require systemic treatment (e.g., vitiligo, psoriasis, or alopecia) will be allowed to enroll.\n9. Has a known history of human immunodeficiency virus (HIV), has hepatitis B surface antigen (HBsAg) positive with hepatitis B virus (HBV) DNA copy number of ≥1000cps\u002Fml or hepatitis C virus (HCV) antibody positive.\n10. Has received a live vaccine within 4 weeks of planned start of study treatment.\n11. Pregnancy or breast feeding.\n12. Cannot complete regular follow-up.","ALL","18 Years","70 Years",{"count":163,"type":164},218,"ESTIMATED","INTERVENTIONAL",[167],"PHASE3","Through multicenter, open-label, randomised clinical trials, we intend to demonstrate that PD-1 treatment added to salvage surgery could further decrease the rate of disease progression and improve the survival outcome of patients with resectable locally recurrent nasopharyngeal carcinoma compared with those treated with salvage surgery alone.",[170,171,172],"Nasopharyngeal Carcinoma","PD-1","Surgery",[174,175,176,177,178],"Nasopharyngeal carcinoma","Recurrent","Salvage surgery","Anti-programmed death-1 antibody","Disease free survival","2021-03-03",{"date":181,"type":182},"2021-03-04","ACTUAL",{"date":179,"type":182},{"date":185,"type":164},"2033-03-03",{"name":5,"class":6},7]