NCT07821242Not yet recruitingPhase 2
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 · Last updated 15 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 46 (estimated)
- First submitted
- 3 Sept 2026
- Start date
- 10 Sept 2026
- Primary completion date
- 23 Jun 2027
- Lead sponsor
- Ke Hu
- Diseases
- Head and neck cancer
- NCT number
- NCT07821242
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 46
- From 10 Sept 2026 to the primary completion date, 23 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Tumor tissue available for HPV / P16 testing; no repeated testing required if prior test results are already available.
- Patients who are assessed to be intolerant to chemotherapy or refuse chemotherapy.
Lab values
- Positive EGFR test result in tumor tissue.
- 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.
- Adequate renal function: serum creatinine ≤1.5×ULN OR creatinine clearance (CrCl) \>60 mL/min calculated by Cockcroft-Gault formula.
- Adequate hepatic function: total bilirubin ≤1.5×ULN; AST ≤2.5×ULN; ALT ≤2.5×ULN.
Age
- Age ≥ 65 years old.
Other
- Histologically or cytologically confirmed stage III-IVB squamous cell carcinoma of head and neck (oral cavity, oropharynx, larynx, hypopharynx).
- ECOG performance status 0-2 OR KPS score ≥ 60.
- At least one measurable lesion according to RECIST version 1.1.
- Estimated life expectancy ≥ 6 months.
- Voluntarily sign written informed consent form and be able to comply with protocol-required visits and procedures.
Who the study is looking for
- Age ≥ 65 years old.
- Histologically or cytologically confirmed stage III-IVB squamous cell carcinoma of head and neck (oral cavity, oropharynx, larynx, hypopharynx).
- Positive EGFR test result in tumor tissue.
- Tumor tissue available for HPV / P16 testing; no repeated testing required if prior test results are already available.
- ECOG performance status 0-2 OR KPS score ≥ 60.
- Patients who are assessed to be intolerant to chemotherapy or refuse chemotherapy.
- At least one measurable lesion according to RECIST version 1.1.
- Estimated life expectancy ≥ 6 months.
- 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.
- Adequate renal function: serum creatinine ≤1.5×ULN OR creatinine clearance (CrCl) \>60 mL/min calculated by Cockcroft-Gault formula.
- Adequate hepatic function: total bilirubin ≤1.5×ULN; AST ≤2.5×ULN; ALT ≤2.5×ULN.
- Voluntarily sign written informed consent form and be able to comply with protocol-required visits and procedures.
Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking Union Medical College Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.