[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100355429":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":39,"centralContacts":44,"locations":52,"responsibleParty":191,"collaborators":33,"id":194,"slug":33,"hasResults":195,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":33,"eligibilityCriteria":199,"healthyVolunteers":195,"sex":200,"minAge":201,"maxAge":202,"enrollmentInfo":203,"targetDuration":33,"studyType":206,"phases":207,"briefSummary":209,"conditions":210,"keywords":212,"overallStatus":55,"whyStopped":33,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":227},{"fullName":5,"class":6},"Sun Yat-sen University","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"PD-1 antibody plus chemoradiotherapy","EXPERIMENTAL","Patients randomized to this arm will receive three cycles of PD-1 antibody (JS001, 240mg every three weeks) combined with GP chemotherapy, then receive IMRT and PD-1 antibody maintenance for eight cycles.",[13,14,15],"Drug: PD-1 blocking antibody","Drug: GP","Radiation: IMRT",{"label":17,"type":18,"description":19,"interventionNames":20},"Chemoradiotherapy","ACTIVE_COMPARATOR","Patients randomized to this arm will receive three cycles of GP chemotherapy, then receive IMRT alone.",[14,15],[22,29,34],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","PD-1 blocking antibody","Toripalimab 240mg, D1, every 3 weeks per cycle",[9],[28],"JS001",{"type":23,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"GP","Gemcitabine 1.0g\u002Fm2, D1 and D8; Cisplatin 80mg\u002Fm2, D1, every 3 weeks per cycle, total three cycles",[17,9],null,{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":33},"RADIATION","IMRT","IMRT 60-66Gy, 1.8-2.0Gy\u002Ff\u002Fday",[17,9],[40],{"name":41,"affiliation":42,"role":43},"Chong Zhao","Sun Yat-Sen University Cancer Center","PRINCIPAL_INVESTIGATOR",[45,50],{"name":46,"role":47,"phone":48,"phoneExt":33,"email":49},"Jingjing Miao","CONTACT","02087342638","miaojingjing90@163.com",{"name":41,"role":47,"phone":48,"phoneExt":33,"email":51},"zhaochong@sysucc.org.cn",[53,69,81,92,103,114,125,136,147,158,169,180],{"facility":54,"status":55,"city":56,"state":57,"zip":33,"country":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"Sun Yat-sen University Cancer Center","RECRUITING","Guangzhou","Guangdong","China",{"type":60,"coordinates":61},"Point",[62,63],113.25,23.11667,{"lat":63,"lon":62},[66],{"name":67,"role":47,"phone":68,"phoneExt":33,"email":51},"Chong Zhao, M.D","+86-13902206160",{"facility":70,"status":71,"city":72,"state":33,"zip":33,"country":58,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"Peking University Third Hospital","NOT_YET_RECRUITING","Beijing",{"type":60,"coordinates":74},[75,76],116.39723,39.9075,{"lat":76,"lon":75},[79],{"name":80,"role":47,"phone":33,"phoneExt":33,"email":33},"Suqing Tian",{"facility":82,"status":71,"city":83,"state":33,"zip":33,"country":58,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"Sichuan Cancer Hospital","Chengdu",{"type":60,"coordinates":85},[86,87],104.06667,30.66667,{"lat":87,"lon":86},[90],{"name":91,"role":47,"phone":33,"phoneExt":33,"email":33},"Shun Lu",{"facility":93,"status":71,"city":94,"state":33,"zip":33,"country":58,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"Fujian Province Cancer Hospital","Fuzhou",{"type":60,"coordinates":96},[97,98],119.30611,26.06139,{"lat":98,"lon":97},[101],{"name":102,"role":47,"phone":33,"phoneExt":33,"email":33},"Shaojun Lin",{"facility":104,"status":55,"city":105,"state":33,"zip":33,"country":58,"cosmosGeoPoint":106,"geoPoint":110,"contacts":111},"Guizhou Cancer Hospital","Guiyang",{"type":60,"coordinates":107},[108,109],106.71667,26.58333,{"lat":109,"lon":108},[112],{"name":113,"role":47,"phone":33,"phoneExt":33,"email":33},"Feng Jin",{"facility":115,"status":71,"city":116,"state":33,"zip":33,"country":58,"cosmosGeoPoint":117,"geoPoint":121,"contacts":122},"Zhejiang Cancer Hospital","Hangzhou",{"type":60,"coordinates":118},[119,120],120.16142,30.29365,{"lat":120,"lon":119},[123],{"name":124,"role":47,"phone":33,"phoneExt":33,"email":33},"Xiaozhong Chen",{"facility":126,"status":71,"city":127,"state":33,"zip":33,"country":58,"cosmosGeoPoint":128,"geoPoint":132,"contacts":133},"Jiangxi Cancer Hospital","Nanchang",{"type":60,"coordinates":129},[130,131],115.85306,28.68396,{"lat":131,"lon":130},[134],{"name":135,"role":47,"phone":33,"phoneExt":33,"email":33},"Jingao Li",{"facility":137,"status":55,"city":138,"state":33,"zip":33,"country":58,"cosmosGeoPoint":139,"geoPoint":143,"contacts":144},"The First Affiliated Hospital of Guangxi Medical University","Nanning",{"type":60,"coordinates":140},[141,142],108.31667,22.81667,{"lat":142,"lon":141},[145],{"name":146,"role":47,"phone":33,"phoneExt":33,"email":33},"Rengshen Wang",{"facility":148,"status":71,"city":149,"state":33,"zip":33,"country":58,"cosmosGeoPoint":150,"geoPoint":154,"contacts":155},"Fudan University Shanghai Cancer Center","Shanghai",{"type":60,"coordinates":151},[152,153],121.45806,31.22222,{"lat":153,"lon":152},[156],{"name":157,"role":47,"phone":33,"phoneExt":33,"email":33},"Chaosu Hu",{"facility":159,"status":55,"city":160,"state":33,"zip":33,"country":58,"cosmosGeoPoint":161,"geoPoint":165,"contacts":166},"Zhongnan Hospital of Wuhan University","Wuhan",{"type":60,"coordinates":162},[163,164],114.26667,30.58333,{"lat":164,"lon":163},[167],{"name":168,"role":47,"phone":33,"phoneExt":33,"email":33},"Conghua Xie",{"facility":170,"status":55,"city":171,"state":33,"zip":33,"country":58,"cosmosGeoPoint":172,"geoPoint":176,"contacts":177},"Xijing Hospital","Xi'an",{"type":60,"coordinates":173},[174,175],108.92861,34.25833,{"lat":175,"lon":174},[178],{"name":179,"role":47,"phone":33,"phoneExt":33,"email":33},"Mei Shi",{"facility":181,"status":71,"city":182,"state":33,"zip":33,"country":58,"cosmosGeoPoint":183,"geoPoint":187,"contacts":188},"The First Affiliated Hospital of Xiamen University","Xiamen",{"type":60,"coordinates":184},[185,186],118.08187,24.47979,{"lat":186,"lon":185},[189],{"name":190,"role":47,"phone":33,"phoneExt":33,"email":33},"Qin Lin",{"type":43,"investigatorFullName":192,"investigatorTitle":193,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"Zhao Chong","Prof.","100355429",false,"NCT03907826","PD-1 Antibody Combined With Chemoradiotherapy in Recurrent Nasopharyngeal Carcinoma Patients","PD-1 Antibody Combined With Chemoradiotheapy vs. Chemoradiotherapy in Recurrent Nasopharyngeal Carcinoma Patients: a Multicenter, Randomised Controlled, Phase III Clinical Trial","Inclusion Criteria:\n\n* Diagnosed as local recurrence ± regional recurrence after ≥1 year of radical treatment;\n* Not suitable for surgery;\n* Newly histologic diagnosis of NPC (WHO II\u002FIII);\n* Clinical stage rII-IVa (AJCC\u002FUICC 8th);\n* ECOG 0-1 point;\n* No treatment to rNPC, such as radiotherapy, chemotherapy, immunotherapy or biotherapy;\n* No contraindications to immunotherapy or radiotherapy;\n* Adequate marrow function: WBC count ≥ 3×10E9\u002FL, NE count ≥ 1.5×10E9\u002FL, HGB ≥ 90g\u002FL, PLT count ≥ 100×10E9\u002FL;\n* Adequate liver function: ALT\u002FAST ≤ 2.5×ULN, TBIL ≤ 2.0×ULN;\n* Adequate renal function: BUN\u002FCRE ≤ 1.5×ULN or endogenous creatinine clearance ≥ 60ml\u002Fmin (Cockcroft-Gault formula);\n* Take effective contraceptions during and two months after treatment;\n* Patients must be informed of the investigational nature of this study and give written informed consent.\n\nExclusion Criteria:\n\n* Treated with anti-tumor Chinese medicine treatment;\n* Have recurrence with local necrosis;\n* Have ≥G3 late toxicities, except for skin, subcutaneous tissue or mucosa;\n* Unexplained fever \\> 38.5 ℃, except for tumor fever;\n* Treated with ≥ 5 days antibiotics one month before enrollment;\n* Have active autoimmune disease (e.g., uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, and asthma requiring bronchodilator therapy); Have a known history of human immunodeficiency virus (HIV), active Hepatitis B (HBV-DNA ≥10E4copiers\u002Fml) or hepatitis C virus (HCV) antibody positive; Have previously treated with PD-1 antibody or other immunotherapy for PD-1\u002FPD-L1 pathway;\n* Have New York Heart Association (NYHA) class 3 or 4, unstable angina, myocardial -infarction within 1 year, or clinically meaningful arrhythmia that requires treatment;\n* Have known allergy to large molecule protein products or any compound of study therapy;\n* Pregnant or breastfeeding;\n* Prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical cancer, and papillary thyroid carcinoma;\n* Have received a live vaccine within 30 days of planned start of study therapy Has psychiatric drug or substance abuse disorders that would interfere with cooperation with the requirements of the trial;\n* Any other condition, including mental illness or domestic\u002Fsocial factors, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interferes with the interpretation of the results.","ALL","18 Years","70 Years",{"count":204,"type":205},212,"ESTIMATED","INTERVENTIONAL",[208],"PHASE3","This is a multicenter, randomized controlled, phase III clinical trial. The purpose of this study is to evaluate the efficacy and adverse effect of PD-1 antibody with chemoradiotherapy versus chemoradiotherapy alone in recurrent nasopharyngeal carcinoma patients.",[211],"Recurrent Nasopharyngeal Carcinoma",[213,214,215,216,217],"PD-1 antibody","Intensity-modulated Radiation Therapy","Efficacy","Adverse effect","chemotherapy","2026-05-06",{"date":220,"type":221},"2026-05-07","ACTUAL",{"date":223,"type":221},"2020-03-01",{"date":225,"type":205},"2028-12",{"name":5,"class":6},12]