[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"recurrent-nasopharyngeal-neoplasms\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:recurrent-nasopharyngeal-neoplasms":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":5},"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":21,"type":22},23,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28,29],"Nasopharyngeal Carcinoma (NPC)","Recurrent Nasopharyngeal Neoplasms",[31,32,33,34,35],"recurrent NPC","re-irradiation","high-low dose radiotherapy","induction radio-immunotherapy","PD-1 inhibitor","RECRUITING","2025-11-30",{"date":39,"type":40},"2025-12-11","ACTUAL",{"date":42,"type":40},"2025-10-10",{"date":44,"type":22},"2029-12-31",{"name":46,"class":47},"Jiangxi Provincial Cancer Hospital","OTHER"]