[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Ke Hu\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":40},{"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":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":35,"leadSponsor":37,"locationsCount":5},"100656074","phase-2-nimotuzumab-plus-radiotherapy-in-elderly-patients-with-locally-advanced-head-and-neck-squamous-cell-carcinoma-100656074",false,"NCT07821242","Nimotuzumab Plus Radiotherapy in Elderly Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma","A Prospective, Single-Arm, Phase II Clinical Study of Nimotuzumab Combined With Radiotherapy for Elderly Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck","NCRHNC","Inclusion Criteria:\n\n1. Age ≥ 65 years old.\n2. Histologically or cytologically confirmed stage III-IVB squamous cell carcinoma of head and neck (oral cavity, oropharynx, larynx, hypopharynx).\n3. Positive EGFR test result in tumor tissue.\n4. Tumor tissue available for HPV \u002F P16 testing; no repeated testing required if prior test results are already available.\n5. ECOG performance status 0-2 OR KPS score ≥ 60.\n6. Patients who are assessed to be intolerant to chemotherapy or refuse chemotherapy.\n7. At least one measurable lesion according to RECIST version 1.1.\n8. Estimated life expectancy ≥ 6 months.\n9. Adequate hematological function: white blood cell count ≥4×10\\^9\u002FL; absolute neutrophil count ≥1.5×10\\^9\u002FL; platelet count ≥100×10\\^9\u002FL; hemoglobin ≥90 g\u002FL.\n10. Adequate renal function: serum creatinine ≤1.5×ULN OR creatinine clearance (CrCl) \\>60 mL\u002Fmin calculated by Cockcroft-Gault formula.\n11. Adequate hepatic function: total bilirubin ≤1.5×ULN; AST ≤2.5×ULN; ALT ≤2.5×ULN.\n12. Voluntarily sign written informed consent form and be able to comply with protocol-required visits and procedures.\n\nExclusion Criteria:\n\n1. Age ≥ 65 years old.\n2. Histologically or cytologically confirmed stage III-IVB squamous cell carcinoma of head and neck (oral cavity, oropharynx, larynx, hypopharynx).\n3. Positive EGFR test result in tumor tissue.\n4. Tumor tissue available for HPV \u002F P16 testing; no repeated testing required if prior test results are already available.\n5. ECOG performance status 0-2 OR KPS score ≥ 60.\n6. Patients who are assessed to be intolerant to chemotherapy or refuse chemotherapy.\n7. At least one measurable lesion according to RECIST version 1.1.\n8. Estimated life expectancy ≥ 6 months.\n9. Adequate hematological function: white blood cell count ≥4×10\\^9\u002FL; absolute neutrophil count ≥1.5×10\\^9\u002FL; platelet count ≥100×10\\^9\u002FL; hemoglobin ≥90 g\u002FL.\n10. Adequate renal function: serum creatinine ≤1.5×ULN OR creatinine clearance (CrCl) \\>60 mL\u002Fmin calculated by Cockcroft-Gault formula.\n11. Adequate hepatic function: total bilirubin ≤1.5×ULN; AST ≤2.5×ULN; ALT ≤2.5×ULN.\n12. Voluntarily sign written informed consent form and be able to comply with protocol-required visits and procedures.","ALL","65 Years",{"count":20,"type":21},46,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a prospective, single-center, open-label, single-arm phase II study. The purpose of this study is to evaluate the efficacy and safety of nimotuzumab combined with concurrent intensity-modulated radiotherapy (IMRT) in elderly patients (≥65 years old) with locally advanced unresectable head-and-neck squamous cell carcinoma (HNSCC) who are unfit for standard concurrent cisplatin-based chemoradiotherapy. Eligible patients will receive standard-dose intensity-modulated radiotherapy together with weekly nimotuzumab. The primary endpoint is 1-year overall survival rate. Secondary endpoints include progression-free survival, objective tumor response rate, locoregional control rate, distant metastasis rate, and treatment-related adverse events. Patients will be followed up for survival, tumor status and safety assessments after treatment completion.",[27,28],"Head & Neck Cancer","Radiotherapy","NOT_YET_RECRUITING","2026-09-10",{"date":32,"type":33},"2026-09-15","ACTUAL",{"date":30,"type":21},{"date":36,"type":21},"2029-03-23",{"name":38,"class":39},"Ke Hu","OTHER",""]