Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 16, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260916-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head & Neck Cancer | Head and Neck Neoplasm | PROBABILISTIC | 0.70 |
| Radiotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nimotuzumab | Drug | Nimotuzumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental: Nimotuzumab Combined with Radiotherapy
- description
- Patients with locally advanced unresectable head-and-neck squamous cell carcinoma receive definitive intensity-modulated radiotherapy (IMRT) to the primary tumor and regional lymph nodes, concurrently with weekly intravenous nimotuzumab during the radiotherapy course. Tumor response is assessed by RECIST 1.1 and adverse events are graded by CTCAE v5.0.
- interventionNames
- Drug: Nimotuzumab
Primary outcomes (1)
- measure
- Objective response rate
- timeFrame
- At 4-week, 12-week after radiotherapy completion, then every 3 months up to 2-year follow-up or until disease progression/withdrawal
- description
- Percentage of patients achieving complete response (CR) or partial response (PR), assessed according to RECIST version 1.1. Only evaluable patients for tumor response will be included in analysis.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (0)
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