[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100618565":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":37,"centralContacts":42,"locations":48,"responsibleParty":63,"collaborators":18,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":18,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":18,"enrollmentInfo":73,"targetDuration":18,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":83,"overallStatus":50,"whyStopped":18,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Shandong Cancer Hospital and Institute","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Radiotherapy plus nimotuzumab","EXPERIMENTAL","radiotherapy plus nimotuzumab",[13,14],"Drug: Nimotuzumab","Radiation: intensity-modulated technique（IMRT）",{"label":16,"type":17,"description":18,"interventionNames":19},"Radiotherapy alone in LA-HNSCC","ACTIVE_COMPARATOR",null,[14],[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Nimotuzumab","Treatment regimen： Nimotuzumab(Experimental Group): nimotuzumab injection 200 mg IV once weekly (QW) for 7 weeks (concurrent with radiotherapy).",[9],[27],"Nimotuzumab injection",{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"RADIATION","intensity-modulated technique（IMRT）","Treatment regimen： Radiotherapy (both groups): intensity-modulated technique (photon IMRT or proton IMPT); total dose 70 Gy (2.0 Gy per fraction, 35 fractions), 5 fractions per week.",[16,9],[34,35,36],"photon IMRT","proton IMPT","intensity-modulated technique",[38],{"name":39,"affiliation":40,"role":41},"Man Hu","Shandong First Medical University Affiliated Cancer Hospital","PRINCIPAL_INVESTIGATOR",[43],{"name":39,"role":44,"phone":45,"phoneExt":46,"email":47},"CONTACT","86+15806698606","（0531）67626151","hu5770@sina.com",[49],{"facility":40,"status":50,"city":51,"state":52,"zip":18,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"RECRUITING","Shandong","Province","China","CN",{"type":56,"coordinates":57},"Point",[58,59],120.48412,40.28464,{"lat":59,"lon":58},[62],{"name":39,"role":44,"phone":45,"phoneExt":46,"email":47},{"type":41,"investigatorFullName":39,"investigatorTitle":40,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"100618565","phase-3-compare-radiotherapy-plus-nimotuzumab-versus-radiotherapy-alone-in-platinum-ineligible-patients-with-locoregionally-advanced-head-and-neck-squamous-cell-carcinoma-100618565",false,"NCT07333274","Compare Radiotherapy Plus Nimotuzumab Versus Radiotherapy Alone in Platinum-ineligible Patients With Locoregionally Advanced Head and Neck Squamous Cell Carcinoma","An Open-label, Prospective, Randomized, Phase III, International Multicenter Clinical Study to Compare Radiotherapy Plus Nimotuzumab Versus Radiotherapy Alone in Platinum-Ineligible Patients With Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC)","Inclusion Criteria:\n\n* Eligible subjects must meet all of the following:\n\n  * Age ≥18 years.\n  * Histologically confirmed stage III-IVB (AJCC 8th edition) head and neck squamous cell carcinoma (including cancers of the oral cavity, oropharynx, hypopharynx, and larynx).\n  * Unsuitable for surgical treatment (defined as: due to patient condition or tumor factors \\[T3-4 N0-3 M0, or T1-2 N2-3 M0\\] or medical reasons, surgery is not feasible; or an R0 resection is not achievable).\n  * Suitable for definitive radiotherapy with curative intent.\n  * At least one of the following reasons for being unsuitable for cisplatin-based chemotherapy:\n* Age ≥65 years and, in the investigator's judgment, unable to tolerate chemotherapy;\n* ECOG Performance Status \\>2 (if this criterion is met, the ECOG criterion listed below may be waived);\n* Renal dysfunction: creatinine clearance (CrCl) \\\u003C50 mL\u002Fmin (Cockcroft-Gault) (if this criterion is met, the renal function criterion listed below may be waived);\n* Severe tinnitus or hearing loss (requires a hearing aid or audiometry shows ≥25 dB loss at two consecutive frequencies);\n* Peripheral neuropathy \\> Grade 1;\n* Inability to receive intravenous hydration (e.g., due to cardiac dysfunction) or other comorbidities, per investigator's judgment.\n\n  * Provide tumor tissue, whenever possible, for EGFR testing; for oropharyngeal cancer, provide tissue for HPV\u002Fp16 testing if feasible (no need to retest if previously tested).\n  * ECOG Performance Status 0-1 (or Karnofsky Performance Status ≥80).\n  * At least one measurable lesion per RECIST 1.1.\n  * Expected survival ≥6 months.\n  * Adequate hematologic function: WBC ≥4×10\\^9\u002FL; absolute neutrophil count ≥1.5×10\\^9\u002FL; platelets ≥100×10\\^9\u002FL; hemoglobin ≥90 g\u002FL.\n  * Adequate renal function: serum creatinine ≤1.5×ULN or CrCl ≥60 mL\u002Fmin (Cockcroft-Gault):\n* Female CrCl = (140 - age) × weight (kg) × 0.85 \u002F (72 × S\\_cr \\[mg\u002FdL\\])\n* Male CrCl = (140 - age) × weight (kg) × 1.00 \u002F (72 × S\\_cr \\[mg\u002FdL\\])\n\n  * Adequate liver function: total bilirubin ≤1.5×ULN; AST ≤2.5×ULN; ALT ≤2.5×ULN.\n  * Voluntary participation: signed written informed consent and ability to comply with visits and procedures.\n\nExclusion Criteria:\n\n* Any of the following excludes enrollment:\n\n  * Receipt of a PD-1 inhibitor, EGFR monoclonal antibody, EGFR-TKI, or anti-angiogenic agent within 4 weeks prior to enrollment.\n  * Participation in another interventional clinical trial within 30 days prior to screening.\n  * History of other malignancy (except cured basal cell carcinoma of the skin).\n  * History of primary immunodeficiency.\n  * Uncontrolled comorbid conditions (e.g., congestive heart failure, severe pulmonary disease, severe liver disease, psychiatric illness).\n  * Known HIV infection, or active viral hepatitis or active tuberculosis.\n  * Major surgery within 90 days before first study treatment, or planned surgery during the study.\n  * Known allergy to nimotuzumab or its excipients.\n  * Deemed unsuitable to participate by the investigator.\n  * Unwilling or unable to sign informed consent.\n  * Receipt of a live vaccine within 30 days before first dose.","ALL","18 Years",{"count":74,"type":75},335,"ESTIMATED","INTERVENTIONAL",[78],"PHASE3","This is an open-label, prospective, randomized, Phase III, international multicenter clinical study to compare radiotherapy plus nimotuzumab versus radiotherapy alone in platinum-ineligible patients with locoregionally advanced head and neck squamous cell carcinoma (LA-HNSCC),",[81,82],"Head & Neck Squamous Cell Carcinoma","Head & Neck Cancer",[23,84,85,86],"Radiotherapy","locoregionally advanced head and neck squamous cell carcinoma","LA-HNSCC","2025-12-30",{"date":89,"type":90},"2026-01-12","ACTUAL",{"date":92,"type":75},"2026-01-05",{"date":94,"type":75},"2030-01-05",{"name":5,"class":6},1]