[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100355429":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":39,"centralContacts":44,"locations":52,"responsibleParty":192,"collaborators":33,"id":195,"slug":196,"hasResults":197,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":33,"eligibilityCriteria":201,"healthyVolunteers":197,"sex":202,"minAge":203,"maxAge":204,"enrollmentInfo":205,"targetDuration":33,"studyType":208,"phases":209,"briefSummary":211,"conditions":212,"keywords":214,"overallStatus":55,"whyStopped":33,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":229},{"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",[53,70,82,93,104,115,126,137,148,159,170,181],{"facility":54,"status":55,"city":56,"state":57,"zip":33,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"Sun Yat-sen University Cancer Center","RECRUITING","Guangzhou","Guangdong","China","CN",{"type":61,"coordinates":62},"Point",[63,64],113.25,23.11667,{"lat":64,"lon":63},[67],{"name":68,"role":47,"phone":69,"phoneExt":33,"email":51},"Chong Zhao, M.D","+86-13902206160",{"facility":71,"status":72,"city":73,"state":33,"zip":33,"country":58,"countryCode":59,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"Peking University Third Hospital","NOT_YET_RECRUITING","Beijing",{"type":61,"coordinates":75},[76,77],116.39723,39.9075,{"lat":77,"lon":76},[80],{"name":81,"role":47,"phone":33,"phoneExt":33,"email":33},"Suqing Tian",{"facility":83,"status":72,"city":84,"state":33,"zip":33,"country":58,"countryCode":59,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"Sichuan Cancer Hospital","Chengdu",{"type":61,"coordinates":86},[87,88],104.06667,30.66667,{"lat":88,"lon":87},[91],{"name":92,"role":47,"phone":33,"phoneExt":33,"email":33},"Shun Lu",{"facility":94,"status":72,"city":95,"state":33,"zip":33,"country":58,"countryCode":59,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"Fujian Province Cancer Hospital","Fuzhou",{"type":61,"coordinates":97},[98,99],119.30611,26.06139,{"lat":99,"lon":98},[102],{"name":103,"role":47,"phone":33,"phoneExt":33,"email":33},"Shaojun Lin",{"facility":105,"status":55,"city":106,"state":33,"zip":33,"country":58,"countryCode":59,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"Guizhou Cancer Hospital","Guiyang",{"type":61,"coordinates":108},[109,110],106.71667,26.58333,{"lat":110,"lon":109},[113],{"name":114,"role":47,"phone":33,"phoneExt":33,"email":33},"Feng Jin",{"facility":116,"status":72,"city":117,"state":33,"zip":33,"country":58,"countryCode":59,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"Zhejiang Cancer Hospital","Hangzhou",{"type":61,"coordinates":119},[120,121],120.16142,30.29365,{"lat":121,"lon":120},[124],{"name":125,"role":47,"phone":33,"phoneExt":33,"email":33},"Xiaozhong Chen",{"facility":127,"status":72,"city":128,"state":33,"zip":33,"country":58,"countryCode":59,"cosmosGeoPoint":129,"geoPoint":133,"contacts":134},"Jiangxi Cancer Hospital","Nanchang",{"type":61,"coordinates":130},[131,132],115.85306,28.68396,{"lat":132,"lon":131},[135],{"name":136,"role":47,"phone":33,"phoneExt":33,"email":33},"Jingao Li",{"facility":138,"status":55,"city":139,"state":33,"zip":33,"country":58,"countryCode":59,"cosmosGeoPoint":140,"geoPoint":144,"contacts":145},"The First Affiliated Hospital of Guangxi Medical University","Nanning",{"type":61,"coordinates":141},[142,143],108.31667,22.81667,{"lat":143,"lon":142},[146],{"name":147,"role":47,"phone":33,"phoneExt":33,"email":33},"Rengshen Wang",{"facility":149,"status":72,"city":150,"state":33,"zip":33,"country":58,"countryCode":59,"cosmosGeoPoint":151,"geoPoint":155,"contacts":156},"Fudan University Shanghai Cancer Center","Shanghai",{"type":61,"coordinates":152},[153,154],121.45806,31.22222,{"lat":154,"lon":153},[157],{"name":158,"role":47,"phone":33,"phoneExt":33,"email":33},"Chaosu Hu",{"facility":160,"status":55,"city":161,"state":33,"zip":33,"country":58,"countryCode":59,"cosmosGeoPoint":162,"geoPoint":166,"contacts":167},"Zhongnan Hospital of Wuhan University","Wuhan",{"type":61,"coordinates":163},[164,165],114.26667,30.58333,{"lat":165,"lon":164},[168],{"name":169,"role":47,"phone":33,"phoneExt":33,"email":33},"Conghua Xie",{"facility":171,"status":55,"city":172,"state":33,"zip":33,"country":58,"countryCode":59,"cosmosGeoPoint":173,"geoPoint":177,"contacts":178},"Xijing Hospital","Xi'an",{"type":61,"coordinates":174},[175,176],108.92861,34.25833,{"lat":176,"lon":175},[179],{"name":180,"role":47,"phone":33,"phoneExt":33,"email":33},"Mei Shi",{"facility":182,"status":72,"city":183,"state":33,"zip":33,"country":58,"countryCode":59,"cosmosGeoPoint":184,"geoPoint":188,"contacts":189},"The First Affiliated Hospital of Xiamen University","Xiamen",{"type":61,"coordinates":185},[186,187],118.08187,24.47979,{"lat":187,"lon":186},[190],{"name":191,"role":47,"phone":33,"phoneExt":33,"email":33},"Qin Lin",{"type":43,"investigatorFullName":193,"investigatorTitle":194,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"Zhao Chong","Prof.","100355429","phase-3-pd-1-antibody-combined-with-chemoradiotherapy-in-recurrent-nasopharyngeal-carcinoma-patients-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":206,"type":207},212,"ESTIMATED","INTERVENTIONAL",[210],"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.",[213],"Recurrent Nasopharyngeal Carcinoma",[215,216,217,218,219],"PD-1 antibody","Intensity-modulated Radiation Therapy","Efficacy","Adverse effect","chemotherapy","2026-05-06",{"date":222,"type":223},"2026-05-07","ACTUAL",{"date":225,"type":223},"2020-03-01",{"date":227,"type":207},"2028-12",{"name":5,"class":6},12]