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NCT07821242

PHASE2

Nimotuzumab Plus Radiotherapy in Elderly Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma

Sponsor: Ke Hu

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

65 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-09-10

Completion Date

2029-03-23

Last Updated

2026-09-15

Healthy Volunteers

Conditions

Head & Neck Cancer Radiotherapy

Interventions

DRUG

Nimotuzumab

Humanized anti-EGFR monoclonal antibody, administered by intravenous infusion once weekly during the whole radiotherapy period.

Inclusion Criteria: 1. Age ≥ 65 years old. 2. Histologically or cytologically confirmed stage III-IVB squamous cell carcinoma of head and neck (oral cavity, oropharynx, larynx, hypopharynx). 3. Positive EGFR test result in tumor tissue. 4. Tumor tissue available for HPV / P16 testing; no repeated testing required if prior test results are already available. 5. ECOG performance status 0-2 OR KPS score ≥ 60. 6. Patients who are assessed to be intolerant to chemotherapy or refuse chemotherapy. 7. At least one measurable lesion according to RECIST version 1.1. 8. Estimated life expectancy ≥ 6 months. 9. Adequate hematological function: white blood cell count ≥4×10\^9/L; absolute neutrophil count ≥1.5×10\^9/L; platelet count ≥100×10\^9/L; hemoglobin ≥90 g/L. 10. Adequate renal function: serum creatinine ≤1.5×ULN OR creatinine clearance (CrCl) \>60 mL/min calculated by Cockcroft-Gault formula. 11. Adequate hepatic function: total bilirubin ≤1.5×ULN; AST ≤2.5×ULN; ALT ≤2.5×ULN. 12. Voluntarily sign written informed consent form and be able to comply with protocol-required visits and procedures. Exclusion Criteria: 1. Age ≥ 65 years old. 2. Histologically or cytologically confirmed stage III-IVB squamous cell carcinoma of head and neck (oral cavity, oropharynx, larynx, hypopharynx). 3. Positive EGFR test result in tumor tissue. 4. Tumor tissue available for HPV / P16 testing; no repeated testing required if prior test results are already available. 5. ECOG performance status 0-2 OR KPS score ≥ 60. 6. Patients who are assessed to be intolerant to chemotherapy or refuse chemotherapy. 7. At least one measurable lesion according to RECIST version 1.1. 8. Estimated life expectancy ≥ 6 months. 9. Adequate hematological function: white blood cell count ≥4×10\^9/L; absolute neutrophil count ≥1.5×10\^9/L; platelet count ≥100×10\^9/L; hemoglobin ≥90 g/L. 10. Adequate renal function: serum creatinine ≤1.5×ULN OR creatinine clearance (CrCl) \>60 mL/min calculated by Cockcroft-Gault formula. 11. Adequate hepatic function: total bilirubin ≤1.5×ULN; AST ≤2.5×ULN; ALT ≤2.5×ULN. 12. Voluntarily sign written informed consent form and be able to comply with protocol-required visits and procedures.

Locations (1)

Peking Union Medical College Hospital

Beijing, China