[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100614297":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":47,"collaborators":20,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":51,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":20,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":70,"overallStatus":30,"whyStopped":20,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Jiangxi Provincial Cancer Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Induction High-Low Dose RT + Anti-PD-1 → Definitive RT → Anti-PD-1 Maintenance","EXPERIMENTAL","Induction: LD-RT 1.5 Gy ×3 (D1-D3) + HD boost 5 Gy ×3 to tumor core; Anti-PD-1 240 mg IV on D1 \\& D22. Definitive RT: from \\~D28, IMRT 2 Gy ×28 (5 days\u002Fweek) without concurrent IO. Maintenance: Anti-PD-1 240 mg IV Q3W up to 12 months. Early stop if CR at 50 Gy or ulcer occurs per protocol.",[13],"Radiation: High-Low Dose Radiotherapy",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"RADIATION","High-Low Dose Radiotherapy","Induction LD-RT 1.5 Gy ×3 (full lesion coverage) + HD boost 5 Gy ×3 (tumor core; carotid\u002Fmucosa sparing \\\u003C3 Gy\u002Ffx); followed by definitive IMRT 2 Gy ×28.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Jingao Li Prof. Jingao Li, MD","CONTACT","8613970866296","ndzhlyy0005@ncu.edu",[28],{"facility":29,"status":30,"city":31,"state":32,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Jiangxi Cancer Hospital","RECRUITING","Nanchang","Jiangxi","330029","China","CN",{"type":37,"coordinates":38},"Point",[39,40],115.85306,28.68396,{"lat":40,"lon":39},[43],{"name":44,"role":24,"phone":45,"phoneExt":20,"email":46},"Tianzhu Lu, PhD","13874877311","lutianzhu2008@163.com",{"type":48,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100614297","phase-2-induction-high-low-dose-radiotherapy-plus-anti-pd-1-followed-by-definitive-radiotherapy-in-recurrent-nasopharyngeal-carcinoma-single-arm-phase-ii-100614297",false,"NCT07277764","Induction High-Low Dose Radiotherapy Plus Anti-PD-1 Followed by Definitive Radiotherapy in Recurrent Nasopharyngeal Carcinoma (Single-Arm Phase II)","Induction Therapy With High-Low Dose Radiotherapy Combined With Anti-PD-1 Monoclonal Antibody Followed by Definitive Radiotherapy in Recurrent Nasopharyngeal Carcinoma: A Single-Arm, Single-Center Phase II Trial","REDEFINE","Inclusion Criteria：\n\nHistologically confirmed non-keratinizing NPC (WHO II\u002FIII); local (± regional) recurrence ≥1 year after prior radical therapy; surgery-ineligible;\n\nrT2-rT4 (AJCC 8th); ECOG 0-1;\n\nAdequate organ function (hematologic, hepatic, renal, coagulation per protocol thresholds);\n\nContraception requirements per protocol; signed informed consent.\n\nExclusion Criteria：\n\nDistant metastasis at recurrence; active necrosis at recurrence; active\u002Fprevious autoimmune disease; prior PD-1\u002FPD-L1 therapy; uncontrolled comorbidities; active infections (HBV\u002FHCV\u002FHIV criteria per protocol); interstitial lung disease\u002Fpneumonitis; pregnancy\u002Flactation; other protocol-specified exclusions.","ALL","18 Years","75 Years",{"count":61,"type":62},23,"ESTIMATED","INTERVENTIONAL",[65],"PHASE2","This single-arm, single-center phase II trial evaluates the safety and efficacy of a non-continuous radio-immunotherapy strategy for recurrent nasopharyngeal carcinoma (NPC) unsuitable for surgery. Induction consists of three fractions of low-dose radiotherapy (1.5 Gy ×3) plus high-dose boosts (5 Gy ×3 to tumor core with carotid\u002Fmucosal sparing) combined with anti-PD-1 (240 mg IV on Day 1 and Day 22). After a 21-28-day interval, definitive IMRT (2 Gy ×28, 5 days\u002Fweek) is delivered without concurrent immunotherapy to minimize immune damage. Anti-PD-1 maintenance (240 mg IV Q3W) starts within 2 weeks after radiotherapy for up to 12 months or until progression\u002Ftoxicity. The primary endpoint is ORR at 3 months post-radiotherapy; secondary endpoints include 3-year OS, 3-year PFS, safety (NCI-CTCAE v5.0), and quality of life (EORTC QLQ-C30). Key eligibility: histologically confirmed non-keratinizing NPC (WHO II\u002FIII), rT2-rT4, ECOG 0-1, adequate organ function.",[68,69],"Nasopharyngeal Carcinoma (NPC)","Recurrent Nasopharyngeal Neoplasms",[71,72,73,74,75],"recurrent NPC","re-irradiation","high-low dose radiotherapy","induction radio-immunotherapy","PD-1 inhibitor","2025-11-30",{"date":78,"type":79},"2025-12-11","ACTUAL",{"date":81,"type":79},"2025-10-10",{"date":83,"type":62},"2029-12-31",{"name":5,"class":6},1]