[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634121":3},{"organization":4,"outcomesModule":7,"designInfo":28,"detailedDescription":23,"studyPopulation":23,"armGroups":34,"interventions":48,"overallOfficials":23,"centralContacts":63,"locations":23,"responsibleParty":73,"collaborators":23,"id":76,"slug":23,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":77,"sex":83,"minAge":84,"maxAge":23,"enrollmentInfo":85,"targetDuration":23,"studyType":88,"phases":89,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":97,"whyStopped":23,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":23},{"fullName":5,"class":6},"Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":23},[9],{"measure":10,"description":11,"timeFrame":12},"Disease-Free Survival (DFS）","From randomization until disease recurrence, metastasis, second primary cancer, or death from any cause","3-year",[14,17,21,25],{"measure":15,"description":16,"timeFrame":12},"Overall Survival (OS)","From enrollment until death from any cause",{"measure":18,"description":19,"timeFrame":20},"Adverse Events (AEs)","From the first dose of nimotuzumab through 30 days after the last dose (approximately 8 weeks total).","30 days after the last dose (approximately 8 weeks total).",{"measure":22,"description":23,"timeFrame":24},"Locoregional Recurrence-Free Survival (LRRFS)",null,"From enrollment until first locoregional recurrence, assessed up to 3 years after last patient enrolled",{"measure":26,"description":23,"timeFrame":27},"Distant Metastasis-Free Survival (DMFS)","From enrollment until first distant metastasis, assessed up to 3 years after last patient enrolled",{"allocation":29,"interventionModel":30,"interventionModelDescription":23,"primaryPurpose":31,"observationalModel":23,"timePerspective":23,"maskingInfo":32},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":33,"maskingDescription":23,"whoMasked":23},"NONE",[35,42],{"label":36,"type":37,"description":38,"interventionNames":39},"IMRT-Nimotuzumab + Benmelstobart","EXPERIMENTAL","Concurrent Nimotuzumab with intensity-modulated radiotherapy (IMRT), followed by adjuvant Benmelstobart therapy",[40,41],"Drug: Nimotuzumab, Benmelstobart","Radiation: Postoperative Radiotherapy",{"label":43,"type":44,"description":45,"interventionNames":46},"IMRT-Nimotuzumab","ACTIVE_COMPARATOR","Concurrent Nimotuzumab with intensity-modulated radiotherapy (IMRT)",[47,41],"Drug: Nimotuzumab",[49,54,58],{"type":50,"name":51,"description":52,"armGroupLabels":53,"otherNames":23},"DRUG","Nimotuzumab","Nimotuzumab: 200 mg on Day 1, once weekly (QW) for a total of 6 cycles.",[43],{"type":50,"name":55,"description":56,"armGroupLabels":57,"otherNames":23},"Nimotuzumab, Benmelstobart","Nimotuzumab: 200 mg on Day 1, once weekly (QW) for a total of 6 cycles.\n\nBemcentinib: 1200 mg on Day 1, every 3 weeks (Q3W) for a total of 9 cycles, initiated 3-4 weeks after completion of radiotherapy.",[36],{"type":59,"name":60,"description":61,"armGroupLabels":62,"otherNames":23},"RADIATION","Postoperative Radiotherapy","Intensity-modulated radiation therapy (IMRT) will be administered at a total dose of 60Gy (2 Gy per fraction, 30 fractions)",[43,36],[64,70],{"name":65,"role":66,"phone":67,"phoneExt":68,"email":69},"Guopei Zhu","CONTACT","86-23271699","5665","antica@gmail.com",{"name":71,"role":66,"phone":67,"phoneExt":68,"email":72},"Wen Jiang","wjiang91@163.com",{"type":74,"investigatorFullName":65,"investigatorTitle":75,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"PRINCIPAL_INVESTIGATOR","Principal Investigator, Clinical Professor","100634121",false,"NCT07535567","Postoperative Radiotherapy With Nimotuzumab ± Benmelstobart in Intermediate-Risk Head and Neck Squamous Cell Carcinoma","Postoperative Radiotherapy And Nimotuzumab With or Without Benmelstobart Adjuvant Therapy in Patients With Head and Neck Squamous Cell Carcinoma Having Intermediate-Risk Pathological Factors: A Multicenter Prospective Randomized Controlled Study","NimoBenSeq","Inclusion Criteria:\n\n* Age ≥ 18 years\n* ECOG performance status: 0-2\n* Histologically confirmed squamous cell carcinoma of the head and neck (oral cavity, oropharynx, larynx); oropharyngeal cancer must be p16-negative (p16 positivity defined as ≥70% staining)\n* Completionof curative-intent surgery, with any of the following intermediate-risk factors present postoperatively:\n\n  ①pT3-4a;\n\n  ②N2 disease (excluding cases with extranodal extension);\n\n  ③Closemargin \\\u003C 5 mm;\n\n  ④Lymphovascular and\u002For perineural invasion;\n\n  ⑤Invasion depth \\> 5mm for T2 oral cavity cancer\n* Laboratory tests must meet the following criteria:\n\n  ①Hematologic parameters (within 14 days without transfusion or blood products): a. Hemoglobin (Hb) ≥80 g\u002FL; b.Absolute neutrophil count (ANC) ≥ 1.0 × 10⁹\u002FL; c. Platelet count (PLT) ≥ 80 × 10⁹\u002FL;\n\n  ②Biochemical parameters: a. Bilirubin (BIL) \\\u003C 1.5 × upperlimit of normal (ULN); b.Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN;\n* Expected survival time ≥ 6 months;\n* Women of child bearing potential must have a negative pregnancy test (serum or urine) within 7 days prior to enrollment and agree to use reliable contraception during the study period; Male subjects must use reliable contraception from before treatment initiation until 120 days after the last dose of study drug\n* With PD-L1 immunohistochemistry testing\n* Participant voluntarily agrees to participate in this study and signs the informed consent form\n\nExclusion Criteria:\n\n* Pregnancy or lactation, or intention to become pregnant during the study period.\n* Presence of active autoimmune disease or immunodeficiency, including but not limited to: myasthenia gravis, interstitial pneumonia, enteritis, autoimmune hepatitis, hypophysitis, vasculitis, nephritis, or hyperthyroidism.\n* Known human immunodeficiency virus (HIV) infection, history of autoimmune diseases, or history of organ transplantation.\n* Use of systemic immunosuppressive drugs within 2 weeks prior to initiation of study treatment, or anticipated need for systemic immunosuppressive therapy during the study treatment period.\n* Diagnosis of another malignancy within 3 years prior to enrollment.\n* History of Grade I or higher myocardial ischemia or myocardial infarction, severe arrhythmia, or ≥ Grade 2 congestive heart failure (New York Heart Association \\[NYHA\\] classification) within 6 months prior to enrollment.\n* Participation in another clinical trial or completion of another clinical trial within 4 weeks prior to enrollment.\n* Prior treatment of immunotherapy (including PD-1\u002FPD-L1\u002FCTLA-4 antibodies) or anti-EGFR agents.\n* Known or suspected allergy to the investigational product or any drug related to this trial.\n* Any other severe medical condition that, in the investigator's judgment, may compromise patient safety or interfere with the subject's ability to complete the study.","ALL","18 Years",{"count":86,"type":87},386,"ESTIMATED","INTERVENTIONAL",[90,91],"PHASE2","PHASE3","A multicenter, randomized, controlled, open-label, Phase II\u002FIII clinical trial designed to evaluate the efficacy and safety of postoperative radiotherapy combined with Nimotuzumab,with or without Bemcentinib, in postoperative head and neck squamouscell cancer patients with intermediate-risk pathological factor. The primary endpoint is the 3-year disease-freesurvival (DFS). A total of 193 patients will be enrolled in both the experimental and control groups, resulting in a total planned enrollment of 386 patients.",[94],"Head and Neck Squamous Cell Carcinoma",[96],"intermediate-risk pathological risk factor","NOT_YET_RECRUITING","2026-04-24",{"date":100,"type":101},"2026-04-30","ACTUAL",{"date":103,"type":87},"2026-05-05",{"date":105,"type":87},"2028-12-31",{"name":5,"class":6}]