[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634121":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":27,"centralContacts":37,"locations":27,"responsibleParty":47,"collaborators":27,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":52,"sex":58,"minAge":59,"maxAge":27,"enrollmentInfo":60,"targetDuration":27,"studyType":63,"phases":64,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":72,"whyStopped":27,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":27},{"fullName":5,"class":6},"Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"IMRT-Nimotuzumab + Benmelstobart","EXPERIMENTAL","Concurrent Nimotuzumab with intensity-modulated radiotherapy (IMRT), followed by adjuvant Benmelstobart therapy",[13,14],"Drug: Nimotuzumab, Benmelstobart","Radiation: Postoperative Radiotherapy",{"label":16,"type":17,"description":18,"interventionNames":19},"IMRT-Nimotuzumab","ACTIVE_COMPARATOR","Concurrent Nimotuzumab with intensity-modulated radiotherapy (IMRT)",[20,14],"Drug: Nimotuzumab",[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Nimotuzumab","Nimotuzumab: 200 mg on Day 1, once weekly (QW) for a total of 6 cycles.",[16],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"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.",[9],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":27},"RADIATION","Postoperative Radiotherapy","Intensity-modulated radiation therapy (IMRT) will be administered at a total dose of 60Gy (2 Gy per fraction, 30 fractions)",[16,9],[38,44],{"name":39,"role":40,"phone":41,"phoneExt":42,"email":43},"Guopei Zhu","CONTACT","86-23271699","5665","antica@gmail.com",{"name":45,"role":40,"phone":41,"phoneExt":42,"email":46},"Wen Jiang","wjiang91@163.com",{"type":48,"investigatorFullName":39,"investigatorTitle":49,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"PRINCIPAL_INVESTIGATOR","Principal Investigator, Clinical Professor","100634121","phase-2-postoperative-radiotherapy-with-nimotuzumab--benmelstobart-in-intermediate-risk-head-and-neck-squamous-cell-carcinoma-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":61,"type":62},386,"ESTIMATED","INTERVENTIONAL",[65,66],"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.",[69],"Head and Neck Squamous Cell Carcinoma",[71],"intermediate-risk pathological risk factor","NOT_YET_RECRUITING","2026-04-24",{"date":75,"type":76},"2026-04-30","ACTUAL",{"date":78,"type":62},"2026-05-05",{"date":80,"type":62},"2028-12-31",{"name":5,"class":6}]