[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100465420":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":42,"centralContacts":47,"locations":54,"responsibleParty":195,"collaborators":52,"id":198,"slug":199,"hasResults":200,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":52,"eligibilityCriteria":204,"healthyVolunteers":200,"sex":205,"minAge":206,"maxAge":207,"enrollmentInfo":208,"targetDuration":52,"studyType":211,"phases":212,"briefSummary":214,"conditions":215,"keywords":217,"overallStatus":57,"whyStopped":52,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":225,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":233},{"fullName":5,"class":6},"Sun Yat-sen University","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Chemoradiotherapy+anti-PD-1","EXPERIMENTAL","Patients in this arm will receive three cycles of GP chemotherapy plus PD-1 antibody, then receive IMRT and PD-1 antibody maintenance for eight cycles.",[13,14,15],"Drug: Toripalimab","Drug: Chemotherapy","Radiation: Intensity modulated radiotherapy",{"label":17,"type":18,"description":19,"interventionNames":20},"Chemoradiotherapy","ACTIVE_COMPARATOR","Patients in this arm will receive three cycles of GP chemotherapy, then receive IMRT.",[14,15],[22,29,35],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Toripalimab","240mg, D1, every 3 weeks per cycle, three cycles with chemotherapy and eight cycles after IMRT",[9],[28],"JS001",{"type":23,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Chemotherapy","Gemcitabine: 1.0g\u002Fm2, D1 and D8, Cisplatin 80mg\u002Fm2, D1, every 3 weeks per cycle, total three cycles",[17,9],[34],"GP",{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"RADIATION","Intensity modulated radiotherapy","total 60-66Gy, 1.8-2.0Gy\u002Ff\u002Fday",[17,9],[41],"IMRT",[43],{"name":44,"affiliation":45,"role":46},"Chong Zhao, MD PhD","Sun Yat-Sen University Cancer Center","PRINCIPAL_INVESTIGATOR",[48],{"name":49,"role":50,"phone":51,"phoneExt":52,"email":53},"Jingjing Miao, PhD","CONTACT","+8613631355201",null,"miaojj@sysucc.org.cn",[55,73,84,96,107,118,129,140,151,162,173,184],{"facility":56,"status":57,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Sun Yat-sen University Cancer Center","RECRUITING","Guangzhou","Guangdong","510060","China","CN",{"type":64,"coordinates":65},"Point",[66,67],113.25,23.11667,{"lat":67,"lon":66},[70,72],{"name":49,"role":50,"phone":71,"phoneExt":52,"email":53},"13631355201",{"name":44,"role":46,"phone":52,"phoneExt":52,"email":52},{"facility":74,"status":57,"city":75,"state":52,"zip":52,"country":61,"countryCode":62,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"Peking University Third Hospital","Beijing",{"type":64,"coordinates":77},[78,79],116.39723,39.9075,{"lat":79,"lon":78},[82],{"name":83,"role":50,"phone":52,"phoneExt":52,"email":52},"Suqing Tian",{"facility":85,"status":86,"city":87,"state":52,"zip":52,"country":61,"countryCode":62,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"Sichuan Cancer Hospital","NOT_YET_RECRUITING","Chengdu",{"type":64,"coordinates":89},[90,91],104.06667,30.66667,{"lat":91,"lon":90},[94],{"name":95,"role":50,"phone":52,"phoneExt":52,"email":52},"Shun Lu",{"facility":97,"status":86,"city":98,"state":52,"zip":52,"country":61,"countryCode":62,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"Fujian Province Cancer Hospital","Fuzhou",{"type":64,"coordinates":100},[101,102],119.30611,26.06139,{"lat":102,"lon":101},[105],{"name":106,"role":50,"phone":52,"phoneExt":52,"email":52},"Shaojun Lin",{"facility":108,"status":86,"city":109,"state":52,"zip":52,"country":61,"countryCode":62,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"Guizhou Cancer Hospital","Guiyang",{"type":64,"coordinates":111},[112,113],106.71667,26.58333,{"lat":113,"lon":112},[116],{"name":117,"role":50,"phone":52,"phoneExt":52,"email":52},"Feng Jin",{"facility":119,"status":57,"city":120,"state":52,"zip":52,"country":61,"countryCode":62,"cosmosGeoPoint":121,"geoPoint":125,"contacts":126},"Zhejiang Cancer Hospital","Hangzhou",{"type":64,"coordinates":122},[123,124],120.16142,30.29365,{"lat":124,"lon":123},[127],{"name":128,"role":50,"phone":52,"phoneExt":52,"email":52},"Xiaozhong Chen",{"facility":130,"status":57,"city":131,"state":52,"zip":52,"country":61,"countryCode":62,"cosmosGeoPoint":132,"geoPoint":136,"contacts":137},"Jiangxi Cancer Hospital","Nanchang",{"type":64,"coordinates":133},[134,135],115.85306,28.68396,{"lat":135,"lon":134},[138],{"name":139,"role":50,"phone":52,"phoneExt":52,"email":52},"Jingao Li",{"facility":141,"status":57,"city":142,"state":52,"zip":52,"country":61,"countryCode":62,"cosmosGeoPoint":143,"geoPoint":147,"contacts":148},"The First Affiliated Hospital of Guangxi Medical University","Nanning",{"type":64,"coordinates":144},[145,146],108.31667,22.81667,{"lat":146,"lon":145},[149],{"name":150,"role":50,"phone":52,"phoneExt":52,"email":52},"Rengshen Wang",{"facility":152,"status":86,"city":153,"state":52,"zip":52,"country":61,"countryCode":62,"cosmosGeoPoint":154,"geoPoint":158,"contacts":159},"Fudan University Shanghai Cancer Center","Shanghai",{"type":64,"coordinates":155},[156,157],121.45806,31.22222,{"lat":157,"lon":156},[160],{"name":161,"role":50,"phone":52,"phoneExt":52,"email":52},"Chaosu Hu",{"facility":163,"status":57,"city":164,"state":52,"zip":52,"country":61,"countryCode":62,"cosmosGeoPoint":165,"geoPoint":169,"contacts":170},"Zhongnan Hospital of Wuhan University","Wuhan",{"type":64,"coordinates":166},[167,168],114.26667,30.58333,{"lat":168,"lon":167},[171],{"name":172,"role":50,"phone":52,"phoneExt":52,"email":52},"Conghua Xie",{"facility":174,"status":57,"city":175,"state":52,"zip":52,"country":61,"countryCode":62,"cosmosGeoPoint":176,"geoPoint":180,"contacts":181},"Xijing Hospital","Xi'an",{"type":64,"coordinates":177},[178,179],108.92861,34.25833,{"lat":179,"lon":178},[182],{"name":183,"role":50,"phone":52,"phoneExt":52,"email":52},"Mei Shi",{"facility":185,"status":86,"city":186,"state":52,"zip":52,"country":61,"countryCode":62,"cosmosGeoPoint":187,"geoPoint":191,"contacts":192},"The First Affiliated Hospital of Xiamen University","Xiamen",{"type":64,"coordinates":188},[189,190],118.08187,24.47979,{"lat":190,"lon":189},[193],{"name":194,"role":50,"phone":52,"phoneExt":52,"email":52},"Qin Lin",{"type":46,"investigatorFullName":196,"investigatorTitle":197,"investigatorAffiliation":5,"oldNameTitle":52,"oldOrganization":52},"Zhao Chong","Prof.","100465420","phase-3-chemoradiotherapy-plus-anti-pd1-in-recurrent-npc-a-multicenter-open-label-randomised-controlled-phase-iii-trial-100465420",false,"NCT05340491","Chemoradiotherapy Plus Anti-PD1 in Recurrent NPC: A Multicenter, Open-label, Randomised, Controlled, Phase III Trial","Chemoradiotherapy Combined With Programmed Death 1 Antibody in Recurrent Nasopharyngeal Carcinoma: A Multicenter, Open-label, Randomised, Controlled, Phase III Trial","Inclusion Criteria:\n\n* Diagnosed as local with or without regional recurrence after ≥1 year of radical treatment;\n* Not suitable for surgery;\n* Histologic diagnosis of NPC (WHO II\u002FIII);\n* TNM stage rII-IVa (AJCC\u002FUICC 8th);\n* ECOG 0-1 point;\n* No treatment to rNPC prior, such as radiotherapy, chemotherapy, immunotherapy or biotherapy;\n* No contraindications to immunotherapy or chemoradiotherapy;\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 ≥10E3copiers\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":209,"type":210},212,"ESTIMATED","INTERVENTIONAL",[213],"PHASE3","This is a multicenter, open-label, randomized, controlled, phase III trial. The purpose of this trial is to evaluate the efficacy and toxicity of anti-PD-1 antibody combined with chemoradiotherapy versus chemoradiotherapy alone in recurrent nasopharyngeal carcinoma patients.",[216],"Nasopharyngeal Carcinoma",[218,219,220,221,222,223],"locoregional relapse","nasopharyngeal carcinoma","chemoradiotherapy","PD-1 antibody","efficacy","toxicity","2026-05-06",{"date":226,"type":227},"2026-05-11","ACTUAL",{"date":229,"type":227},"2022-04-01",{"date":231,"type":210},"2028-12",{"name":5,"class":6},12]