[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100573716":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":42,"centralContacts":46,"locations":54,"responsibleParty":274,"collaborators":277,"id":281,"slug":282,"hasResults":283,"nctId":284,"briefTitle":285,"officialTitle":286,"acronym":28,"eligibilityCriteria":287,"healthyVolunteers":283,"sex":288,"minAge":289,"maxAge":290,"enrollmentInfo":291,"targetDuration":28,"studyType":294,"phases":295,"briefSummary":297,"conditions":298,"keywords":301,"overallStatus":110,"whyStopped":28,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":306,"startDateStruct":309,"completionDateStruct":311,"leadSponsor":313,"locationsCount":314},{"fullName":5,"class":6},"Sun Yat-sen University","OTHER",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"QL1706 Arm","EXPERIMENTAL","Patients will receive induction chemotherapy with gemcitabine (1g\u002Fm2, d1 \\& 8 of every cycle) and cisplatin (80mg\u002Fm2, d1 of every cycle), every 3 weeks for 3 cycles before radiation. Definitive intensity-modulated radiotherapy (IMRT) of 6996cGy in 33 fractions will be given. Concurrent cisplatin of 100mg\u002Fm2 will be administered every 3 weeks for 2 cycles during IMRT. QL1706 5mg\u002Fkg will be given every 3 weeks for 3 cycles in induction chemotherapy and for 9 cycles in adjuvant chemotherapy, started on day 1 of induction chemotherapy and adjuvant chemotherapy, respectively.",[13,14,15,16],"Drug: QL1706","Drug: Gemcitabine","Drug: Cisplatin","Radiation: Intensity-modulated radiotherapy",{"label":18,"type":19,"description":20,"interventionNames":21},"Chemoradiation Arm","ACTIVE_COMPARATOR","Patients will receive induction chemotherapy with gemcitabine (1g\u002Fm2, d1 \\& 8 of every cycle) and cisplatin (80mg\u002Fm2, d1 of every cycle), every 3 weeks for 3 cycles before radiation. Definitive intensity-modulated radiotherapy (IMRT) of 6996cGy in 33 fractions will be given. Concurrent cisplatin of 100mg\u002Fm2 will be administered every 3 weeks for 2 cycles during IMRT.",[14,15,16],[23,29,33,37],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","QL1706","QL1706 5mg\u002Fkg will be given every 3 weeks for 3 cycles in induction chemotherapy and for 9 cycles in adjuvant chemotherapy, started on day 1 of induction chemotherapy and adjuvant chemotherapy, respectively.",[9],null,{"type":24,"name":30,"description":31,"armGroupLabels":32,"otherNames":28},"Gemcitabine","Gemcitabine 1g\u002Fm2, d1 \\& 8 of every cycle, every 3 weeks for 3 cycles before radiation.",[18,9],{"type":24,"name":34,"description":35,"armGroupLabels":36,"otherNames":28},"Cisplatin","Induction cisplatin 80mg\u002Fm2, every 3 weeks for 3 cycles before radiation; Concurrent cisplatin 100mg\u002Fm2, every 3 weeks for 2 cycles during radiation",[18,9],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":28},"RADIATION","Intensity-modulated radiotherapy","Definitive intensity-modulated radiotherapy (IMRT) of 6996cGy will be given in 33 fractions.",[18,9],[43],{"name":44,"affiliation":5,"role":45},"Jun Ma, M.D.","PRINCIPAL_INVESTIGATOR",[47,51],{"name":44,"role":48,"phone":49,"phoneExt":28,"email":50},"CONTACT","+862087343469","majun2@mail.sysu.edu.cn",{"name":52,"role":48,"phone":28,"phoneExt":28,"email":53},"Rui Guo, M.D.","guorui@sysucc.org.cn",[55,73,85,96,108,116,127,140,152,165,173,181,189,202,210,223,236,249,262],{"facility":56,"status":57,"city":58,"state":59,"zip":28,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"Fujian Cancer Hospital","NOT_YET_RECRUITING","Fuzhou","Fujian","China","CN",{"type":63,"coordinates":64},"Point",[65,66],119.30611,26.06139,{"lat":66,"lon":65},[69,71],{"name":70,"role":48,"phone":28,"phoneExt":28,"email":28},"Chuan-Ben Chen",{"name":72,"role":48,"phone":28,"phoneExt":28,"email":28},"Su-Fang Qiu",{"facility":74,"status":57,"city":75,"state":76,"zip":28,"country":60,"countryCode":61,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Dongguan People's Hospital","Dongguan","Guangdong",{"type":63,"coordinates":78},[79,80],113.74866,23.01797,{"lat":80,"lon":79},[83],{"name":84,"role":48,"phone":28,"phoneExt":28,"email":28},"Zhi-Gang Liu",{"facility":86,"status":57,"city":87,"state":76,"zip":28,"country":60,"countryCode":61,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"First People's Hospital of Foshan","Foshan",{"type":63,"coordinates":89},[90,91],113.13148,23.02677,{"lat":91,"lon":90},[94],{"name":95,"role":48,"phone":28,"phoneExt":28,"email":28},"Ning Zhang",{"facility":97,"status":57,"city":98,"state":76,"zip":99,"country":60,"countryCode":61,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"Guangzhou Panyu Central Hospital","Guangzhou","510060",{"type":63,"coordinates":101},[102,103],113.25,23.11667,{"lat":103,"lon":102},[106],{"name":107,"role":48,"phone":28,"phoneExt":28,"email":28},"Guo-Rong Zou",{"facility":109,"status":110,"city":98,"state":76,"zip":99,"country":60,"countryCode":61,"cosmosGeoPoint":111,"geoPoint":113,"contacts":114},"Sun Yat-Sen University Cancer Center","RECRUITING",{"type":63,"coordinates":112},[102,103],{"lat":103,"lon":102},[115],{"name":44,"role":48,"phone":49,"phoneExt":28,"email":50},{"facility":117,"status":57,"city":118,"state":76,"zip":28,"country":60,"countryCode":61,"cosmosGeoPoint":119,"geoPoint":123,"contacts":124},"Zhongshan People's Hospital","Zhongshan",{"type":63,"coordinates":120},[121,122],113.37912,22.52306,{"lat":122,"lon":121},[125],{"name":126,"role":48,"phone":28,"phoneExt":28,"email":28},"Feng Lei",{"facility":128,"status":57,"city":129,"state":130,"zip":131,"country":60,"countryCode":61,"cosmosGeoPoint":132,"geoPoint":136,"contacts":137},"Cancer Hospital of Guangxi Medical University","Nanning","Guangxi","530000",{"type":63,"coordinates":133},[134,135],108.31667,22.81667,{"lat":135,"lon":134},[138],{"name":139,"role":48,"phone":28,"phoneExt":28,"email":28},"Xiao-Dong Zhu, M.D.",{"facility":141,"status":57,"city":142,"state":143,"zip":28,"country":60,"countryCode":61,"cosmosGeoPoint":144,"geoPoint":148,"contacts":149},"Cancer Hospital of Guizhou Medical University","Guiyang","Guizhou",{"type":63,"coordinates":145},[146,147],106.71667,26.58333,{"lat":147,"lon":146},[150],{"name":151,"role":48,"phone":28,"phoneExt":28,"email":28},"Feng Jin, M.D.",{"facility":153,"status":57,"city":154,"state":155,"zip":156,"country":60,"countryCode":61,"cosmosGeoPoint":157,"geoPoint":161,"contacts":162},"Hubei Province Cancer Hosiptal","Wuhan","Hubei","430000",{"type":63,"coordinates":158},[159,160],114.26667,30.58333,{"lat":160,"lon":159},[163],{"name":164,"role":48,"phone":28,"phoneExt":28,"email":28},"De-Sheng Hu, M.D.",{"facility":166,"status":57,"city":154,"state":155,"zip":156,"country":60,"countryCode":61,"cosmosGeoPoint":167,"geoPoint":169,"contacts":170},"Renmin Hospital of Wuhan University",{"type":63,"coordinates":168},[159,160],{"lat":160,"lon":159},[171],{"name":172,"role":48,"phone":28,"phoneExt":28,"email":28},"Xiang-Pan Li, M.D.",{"facility":174,"status":57,"city":154,"state":155,"zip":156,"country":60,"countryCode":61,"cosmosGeoPoint":175,"geoPoint":177,"contacts":178},"Tongji Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology",{"type":63,"coordinates":176},[159,160],{"lat":160,"lon":159},[179],{"name":180,"role":48,"phone":28,"phoneExt":28,"email":28},"Guang-Yuan Hu, M.D.",{"facility":182,"status":57,"city":154,"state":155,"zip":156,"country":60,"countryCode":61,"cosmosGeoPoint":183,"geoPoint":185,"contacts":186},"Union Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology",{"type":63,"coordinates":184},[159,160],{"lat":160,"lon":159},[187],{"name":188,"role":48,"phone":28,"phoneExt":28,"email":28},"Kun-Yu Yang, M.D.",{"facility":190,"status":57,"city":191,"state":192,"zip":193,"country":60,"countryCode":61,"cosmosGeoPoint":194,"geoPoint":198,"contacts":199},"Hunan Cancer Hospital","Changsha","Hunan","410000",{"type":63,"coordinates":195},[196,197],112.97087,28.19874,{"lat":197,"lon":196},[200],{"name":201,"role":48,"phone":28,"phoneExt":28,"email":28},"Ya-Qian Han",{"facility":203,"status":57,"city":191,"state":192,"zip":28,"country":60,"countryCode":61,"cosmosGeoPoint":204,"geoPoint":206,"contacts":207},"Xiangya Hospital of Central South University",{"type":63,"coordinates":205},[196,197],{"lat":197,"lon":196},[208],{"name":209,"role":48,"phone":28,"phoneExt":28,"email":28},"Liang-Fang Shen, M.D.",{"facility":211,"status":57,"city":212,"state":213,"zip":214,"country":60,"countryCode":61,"cosmosGeoPoint":215,"geoPoint":219,"contacts":220},"Jiangsu Cancer Hospital","Nanjing","Jiangsu","210000",{"type":63,"coordinates":216},[217,218],118.77778,32.06167,{"lat":218,"lon":217},[221],{"name":222,"role":48,"phone":28,"phoneExt":28,"email":28},"Xia He, M.D.",{"facility":224,"status":57,"city":225,"state":226,"zip":227,"country":60,"countryCode":61,"cosmosGeoPoint":228,"geoPoint":232,"contacts":233},"The Eye and ENT Hospital of Fudan University","Shanghai","Shanghai Municipality","200000",{"type":63,"coordinates":229},[230,231],121.45806,31.22222,{"lat":231,"lon":230},[234],{"name":235,"role":48,"phone":28,"phoneExt":28,"email":28},"Xiao-Shen Wang, M.D.",{"facility":237,"status":57,"city":238,"state":239,"zip":240,"country":60,"countryCode":61,"cosmosGeoPoint":241,"geoPoint":245,"contacts":246},"Sichuan Cancer Hospital","Chengdu","Sichuan","610001",{"type":63,"coordinates":242},[243,244],104.06667,30.66667,{"lat":244,"lon":243},[247],{"name":248,"role":48,"phone":28,"phoneExt":28,"email":28},"Shi-chuan Zhang, M.D.",{"facility":250,"status":57,"city":251,"state":252,"zip":253,"country":60,"countryCode":61,"cosmosGeoPoint":254,"geoPoint":258,"contacts":259},"Tianjin Medical University Cancer Institute ＆ Hospital","Tianjin","Tianjin Municipality","30000",{"type":63,"coordinates":255},[256,257],117.17667,39.14222,{"lat":257,"lon":256},[260],{"name":261,"role":48,"phone":28,"phoneExt":28,"email":28},"Pei-guo Wang, M.D.",{"facility":263,"status":57,"city":59,"state":264,"zip":265,"country":60,"countryCode":61,"cosmosGeoPoint":266,"geoPoint":270,"contacts":271},"The First Affiliated Hospital of Xiamen University","Xiamen","361000",{"type":63,"coordinates":267},[268,269],106.12972,28.92651,{"lat":269,"lon":268},[272],{"name":273,"role":48,"phone":28,"phoneExt":28,"email":28},"Qin Lin, M.D.",{"type":45,"investigatorFullName":275,"investigatorTitle":276,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"Jun Ma, MD","Professor",[278],{"name":279,"class":280},"Qilu Pharmaceutical Co., Ltd.","INDUSTRY","100573716","phase-3-ql1706-pd-1ctla-4-bi-specific-antibody-and-chemoradiotherapy-in-locoregionally-advanced-nasopharyngeal-carcinoma-100573716",false,"NCT06749899","QL1706 (PD-1\u002FCTLA-4 Bi-specific Antibody) and Chemoradiotherapy in Locoregionally-advanced Nasopharyngeal Carcinoma.","QL1706 (Iparomlimab and Tuvonralimab Injection,PD-1\u002F CTLA-4 Bi-specific Antibody) Combined With Chemoradiotherapy Versus Chemoradiotherapy Alone in High-Risk Locoregionally Advanced Nasopharyngeal Carcinoma：A Randomized, Controlled, Multicenter Phase III Clinical Study.","Inclusion Criteria\n\n1. Age ≥18 and ≤65 years\n2. Patients with histologically confirmed non-keratinizing nasopharyngeal carcinoma according to WHO criteria.\n3. Tumor staged as T4N1 and T1-4N2-3 (AJCC 9th)\n\n   * Stage II: T1-3N2\n   * Stage III: T1-4N3, T4N1-2\n4. Eastern Cooperative Oncology Group performance score of 0-11.\n5. Adequate marrow function: white blood cell count \\> 4 × 10⁹\u002FLhemoglobin \\>90g\u002FL and platelet count \\>100×10⁹\u002FL\n6. Adequate hepatic and renal function：\n\n   * Total bilirubin ≤ 1.5 × upper limit of normal (ULN)\n   * Alanine Aminotransferase (ALT)\u002FAspartate Aminotransferase (AST) ≤2.5×ULN\n   * Alkaline phosphatase ≤ 2.5 × ULN\n   * clearance rate ≥ 60 ml\u002Fmin\n7. Other laboratory and clinical criteria\n\n   * Normal thyroid function, serum amylase and lipase, pituitary hormone levels, inflammatory markers, cardiac enzyme tests and electrocardiogram (ECG)\n   * For patients aged \\>50 years with a history of smoking, normal pulmonary function test (PFT) results are required\n   * For patients with abnormal ECG findings or a prior history of cardiovascular disease (not meeting any exclusion criteria listed in Item 8), additional assessments including myocardial function evaluation and cardiac ultrasound (echocardiography) must be performed, with results within normal limits\n8. Patients must be informed of the investigational nature of this study and give written informed consent, and be willing and able to comply with the study schedule, including follow-up visits, treatment procedures, laboratory testing, and other protocol-related requirements.\n9. Women of childbearing potential (WOCBP) must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of study drug (e.g., condoms, physician-guided regular use of oral contraceptives).\n\nExclusion Criteria\n\n1. Positive for hepatitis B surface antigen (HBsAg) with hepatitis B virus DNA \\>1×103 copies\u002FmL, positive for anti-hepatitis C virus (HCV) antibody , positive for anti-hepatitis C virus (HCV) antibody\n2. Positive for anti-HIV antibody or diagnosed with acquired immunodeficiency syndrome (AIDS).\n3. Active pulmonary tuberculosis: Patients with a history of active tuberculosis within the past year should be excluded regardless of treatment status. Patients with a history of active pulmonary tuberculosis more than one year prior should also be excluded, unless they received confirmed and regular anti-tuberculosis treatment.\n4. Active, known, or suspected autoimmune diseases, including but not limited to uveitis, colitis, hepatitis, hypophysitis, nephritis, vasculitis, systemic lupus erythematosus, hyperthyroidism, hypothyroidism, and asthma requiring bronchodilators. Type I diabetes, hypothyroidism treated with replacement therapy, and skin disease that doesn't require systemic treatment (e.g., vitiligo, psoriasis, or alopecia) are allowed.\n5. Thymic epithelial tumors (TETs), including thymoma, thymic carcinoma, and thymic neuroendocrine tumors (NETTs).\n6. History of interstitial lung disease or pneumonia requiring oral or intravenous corticosteroids within the past year; use of vancomycin within the past month.\n7. Ongoing chronic systemic corticosteroid therapy (equivalent to or greater than prednisone \\>10mg per day) or any other immunosuppressive therapy. Patients received inhale or topical corticosteroid are allowed.\n8. Uncontrolled cardiac conditions, such as:\n\n   * Heart failure with New York Heart Association (NYHA) classification ≥ Class II;\n   * Unstable angina;\n   * History of myocardial infarction within the past year;\n   * Supraventricular or ventricular arrhythmias requiring treatment or intervention\n9. Pregnant or breastfeeding women (pregnancy testing should be considered for women of childbearing potential with active sexual life)\n10. History or presence of other malignancies, except for adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, and papillary thyroid carcinoma.\n11. Known hypersensitivity to macromolecule protein products or any component of QL1706.\n12. Active infections requiring systemic treatment within 1 week prior to enrollment.\n13. Administration of live vaccines within 30 days prior to the first dose of epalurilimab-tovorolimab.\n14. History of organ transplantation or hematopoietic stem cell transplantation.\n15. Any other condition assessed by the investigator as potentially compromising patient safety or compliance, such as severe illnesses requiring urgent treatment (including psychiatric disorders), significantly abnormal laboratory values, or other psychological, familial, or social risk factors.","ALL","18 Years","65 Years",{"count":292,"type":293},580,"ESTIMATED","INTERVENTIONAL",[296],"PHASE3","The trial aimed to compare QL1706 combined with induction chemotherapy plus concurrent chemoradiotherapy (IC+CCRT) versus IC+CCRT alone in High-risk Locoregionally-Advanced Nasopharyngeal Carcinoma (LANPC).",[299,300],"Nasopharyngeal Cancinoma (NPC)","Nasopharyngeal Cancer",[302,303,304],"Immunotherapy","PD-1\u002FCTLA-4 Bi-specific Antibody","Chemoradiotherapy","2025-05-19",{"date":307,"type":308},"2025-05-22","ACTUAL",{"date":310,"type":308},"2025-05-04",{"date":312,"type":293},"2030-12-01",{"name":109,"class":6},19]