[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100469819":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":32,"responsibleParty":52,"collaborators":20,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":20,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":20,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":20,"overallStatus":35,"whyStopped":20,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Sun Yat-sen University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Envafolimab group","EXPERIMENTAL","Envafolimab is a PD-L1 antibody by hypodermic injection. Envafolimab will be administrated with 300mg each time, every three weeks for a total of 22 cycles since the first day of induction chemotherapy.",[13],"Drug: Envafolimab Plus Chemoradiotherapy",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Envafolimab Plus Chemoradiotherapy","Envafolimab was administrated with 300mg each time, every three weeks for a total of 22 cycles since the first day of induction chemotherapy.",[9],null,[22,28],{"name":23,"role":24,"phone":25,"phoneExt":26,"email":27},"Fei Han","CONTACT","13822113698","86","hanfei@sysucc.org.cn",{"name":29,"role":24,"phone":30,"phoneExt":26,"email":31},"Xiaohui Wang","18826260661","wangxh@sysucc.org.cn",[33],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Sun Yat-sen University Cancer Center","RECRUITING","Guangzhou","Guangdong","510060","China","CN",{"type":42,"coordinates":43},"Point",[44,45],113.25,23.11667,{"lat":45,"lon":44},[48,49],{"name":23,"role":24,"phone":25,"phoneExt":26,"email":27},{"name":50,"role":51,"phone":20,"phoneExt":20,"email":20},"Fei Han, MD","PRINCIPAL_INVESTIGATOR",{"type":51,"investigatorFullName":23,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"professor","100469819","phase-2-envafolimab-plus-chemoradiotherapy-for-locally-advanced-npc-a-prospective-single-armed-phase-ii-trial-100469819",false,"NCT05397769","Envafolimab Plus Chemoradiotherapy for Locally Advanced NPC, a Prospective, Single Armed Phase II Trial.","Envafolimab Plus Chemoradiotherapy for Locally Advanced Nasopharyngeal Carcinoma, a Prospective, Single Armed Phase II Trial.","Inclusion Criteria:\n\n* ECOG 0-1\n* histologically confirmed non-keratinizing carcinoma (WHO type II or III) of nasal pharynx\n* stage III-IVa （AJCC\u002FUICC 8th ）, untreated NPC patients\n* NE≥ 1.5×10E9\u002FL, HGB ≥ 100g\u002FL and PLT ≥100×10E9\u002FL\n* ALT≤ 1.5 upper limit of normal (ULN), AST≤ 1.5ULN and bilirubin ≤ 1.5ULN\n* creatinine\\\u003C1.5×ULN\n\nExclusion Criteria:\n\n* recurrent or metastatic NPC patients\n* histologically confirmed keratinizing carcinoma (WHO type I) of nasal pharynx\n* already received radiation or chemotherapy\n* pregnant or lactating women, or women of childbearing age without birth control\n* HIV (+)\n* had other cancers before\n* used immune checkpoint inhibitor(CTLA-4、PD-1、PD-L1 etc.) before\n* complications requiring long-term treatment with immunosuppressive drugs or systemic or local use of corticosteroids with immunosuppressive dose\n* with immune deficiency diseases, or a history of organ transplantation (including but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism and hypothyroidism; Patients with vitiligo or asthma in childhood who have completely relieved and do not need any intervention after adulthood can be included; Asthma requiring medical intervention with bronchodilators cannot be included)\n* use of massive dose of glucocorticoids within 4 weeks before enrollment\n* laboratory test values do not meet relevant standards within 7 days before enrollment\n* significantly lower functions of heart, liver, lung, kidney and bone marrow\n* serious or uncontrolled medical diseases or infections\n* participating other clinical trial in the same time\n* HBsAg (+) and HBV DNA \\>1×10E3 copiers \u002FmL\n* HCV (+) unless HCV RNA PCR(-)\n* with any other treatment contraindications","ALL","18 Years","65 Years",{"count":65,"type":66},36,"ESTIMATED","INTERVENTIONAL",[69],"PHASE2","Patients diagnosed with locally advanced nasopharyngeal carcinoma will be recruited in this study. All the patients will get 3 cycles of GP+ Envafolimab for the induction chemotherapy. After that, the patients will receive concurrent chemoradiotherapy. Radiotherapy will be given by IMRT, under the dose of GTVnx 68-70Gy\u002F30-33f, 5d\u002Fw,6-7w, during which, every patient would receive 2 cycles of DDP+Envafolimab as concurrent chemotherapy. Then patients would receive Envafolimab every 3 weeks for maintenance treatment for a year, until disease progression or intolerance of treatment. . We aim to evaluate the three years progression free survival of these patients by the combination of Envafolimab with curative chemoradiotherapy.",[72,73,74,75],"Locally Advanced Nasopharyngeal Carcinoma","Envafolimab","Induction Chemotherapy","PD-L1","2022-08-09",{"date":78,"type":79},"2022-08-10","ACTUAL",{"date":81,"type":79},"2022-06-08",{"date":83,"type":66},"2026-12-31",{"name":5,"class":6},1]