[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100465420":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":42,"centralContacts":47,"locations":54,"responsibleParty":194,"collaborators":52,"id":197,"slug":52,"hasResults":198,"nctId":199,"briefTitle":200,"officialTitle":201,"acronym":52,"eligibilityCriteria":202,"healthyVolunteers":198,"sex":203,"minAge":204,"maxAge":205,"enrollmentInfo":206,"targetDuration":52,"studyType":209,"phases":210,"briefSummary":212,"conditions":213,"keywords":215,"overallStatus":57,"whyStopped":52,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":231},{"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",[55,72,83,95,106,117,128,139,150,161,172,183],{"facility":56,"status":57,"city":58,"state":59,"zip":60,"country":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"Sun Yat-sen University Cancer Center","RECRUITING","Guangzhou","Guangdong","510060","China",{"type":63,"coordinates":64},"Point",[65,66],113.25,23.11667,{"lat":66,"lon":65},[69,71],{"name":49,"role":50,"phone":70,"phoneExt":52,"email":53},"13631355201",{"name":44,"role":46,"phone":52,"phoneExt":52,"email":52},{"facility":73,"status":57,"city":74,"state":52,"zip":52,"country":61,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"Peking University Third Hospital","Beijing",{"type":63,"coordinates":76},[77,78],116.39723,39.9075,{"lat":78,"lon":77},[81],{"name":82,"role":50,"phone":52,"phoneExt":52,"email":52},"Suqing Tian",{"facility":84,"status":85,"city":86,"state":52,"zip":52,"country":61,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Sichuan Cancer Hospital","NOT_YET_RECRUITING","Chengdu",{"type":63,"coordinates":88},[89,90],104.06667,30.66667,{"lat":90,"lon":89},[93],{"name":94,"role":50,"phone":52,"phoneExt":52,"email":52},"Shun Lu",{"facility":96,"status":85,"city":97,"state":52,"zip":52,"country":61,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"Fujian Province Cancer Hospital","Fuzhou",{"type":63,"coordinates":99},[100,101],119.30611,26.06139,{"lat":101,"lon":100},[104],{"name":105,"role":50,"phone":52,"phoneExt":52,"email":52},"Shaojun Lin",{"facility":107,"status":85,"city":108,"state":52,"zip":52,"country":61,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"Guizhou Cancer Hospital","Guiyang",{"type":63,"coordinates":110},[111,112],106.71667,26.58333,{"lat":112,"lon":111},[115],{"name":116,"role":50,"phone":52,"phoneExt":52,"email":52},"Feng Jin",{"facility":118,"status":57,"city":119,"state":52,"zip":52,"country":61,"cosmosGeoPoint":120,"geoPoint":124,"contacts":125},"Zhejiang Cancer Hospital","Hangzhou",{"type":63,"coordinates":121},[122,123],120.16142,30.29365,{"lat":123,"lon":122},[126],{"name":127,"role":50,"phone":52,"phoneExt":52,"email":52},"Xiaozhong Chen",{"facility":129,"status":57,"city":130,"state":52,"zip":52,"country":61,"cosmosGeoPoint":131,"geoPoint":135,"contacts":136},"Jiangxi Cancer Hospital","Nanchang",{"type":63,"coordinates":132},[133,134],115.85306,28.68396,{"lat":134,"lon":133},[137],{"name":138,"role":50,"phone":52,"phoneExt":52,"email":52},"Jingao Li",{"facility":140,"status":57,"city":141,"state":52,"zip":52,"country":61,"cosmosGeoPoint":142,"geoPoint":146,"contacts":147},"The First Affiliated Hospital of Guangxi Medical University","Nanning",{"type":63,"coordinates":143},[144,145],108.31667,22.81667,{"lat":145,"lon":144},[148],{"name":149,"role":50,"phone":52,"phoneExt":52,"email":52},"Rengshen Wang",{"facility":151,"status":85,"city":152,"state":52,"zip":52,"country":61,"cosmosGeoPoint":153,"geoPoint":157,"contacts":158},"Fudan University Shanghai Cancer Center","Shanghai",{"type":63,"coordinates":154},[155,156],121.45806,31.22222,{"lat":156,"lon":155},[159],{"name":160,"role":50,"phone":52,"phoneExt":52,"email":52},"Chaosu Hu",{"facility":162,"status":57,"city":163,"state":52,"zip":52,"country":61,"cosmosGeoPoint":164,"geoPoint":168,"contacts":169},"Zhongnan Hospital of Wuhan University","Wuhan",{"type":63,"coordinates":165},[166,167],114.26667,30.58333,{"lat":167,"lon":166},[170],{"name":171,"role":50,"phone":52,"phoneExt":52,"email":52},"Conghua Xie",{"facility":173,"status":57,"city":174,"state":52,"zip":52,"country":61,"cosmosGeoPoint":175,"geoPoint":179,"contacts":180},"Xijing Hospital","Xi'an",{"type":63,"coordinates":176},[177,178],108.92861,34.25833,{"lat":178,"lon":177},[181],{"name":182,"role":50,"phone":52,"phoneExt":52,"email":52},"Mei Shi",{"facility":184,"status":85,"city":185,"state":52,"zip":52,"country":61,"cosmosGeoPoint":186,"geoPoint":190,"contacts":191},"The First Affiliated Hospital of Xiamen University","Xiamen",{"type":63,"coordinates":187},[188,189],118.08187,24.47979,{"lat":189,"lon":188},[192],{"name":193,"role":50,"phone":52,"phoneExt":52,"email":52},"Qin Lin",{"type":46,"investigatorFullName":195,"investigatorTitle":196,"investigatorAffiliation":5,"oldNameTitle":52,"oldOrganization":52},"Zhao Chong","Prof.","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":207,"type":208},212,"ESTIMATED","INTERVENTIONAL",[211],"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.",[214],"Nasopharyngeal Carcinoma",[216,217,218,219,220,221],"locoregional relapse","nasopharyngeal carcinoma","chemoradiotherapy","PD-1 antibody","efficacy","toxicity","2026-05-06",{"date":224,"type":225},"2026-05-11","ACTUAL",{"date":227,"type":225},"2022-04-01",{"date":229,"type":208},"2028-12",{"name":5,"class":6},12]