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

NCT07821242 | Not Yet Recruiting Phase 2 DMC

• 2 other identifiers: K9728I-26PJ0638
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Head & Neck Cancer; Radiotherapy

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  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.

  At 4-week, 12-week after radiotherapy completion, then every 3 months up to 2-year follow-up or until disease progression/withdrawal

Secondary Outcomes (3)

• 2-year progression-free survival rate

  From start of study treatment up to 24 months

• 2-year locoregional control rate

  From start of study treatment through 2-year follow-up

• Overall survival

  From start of study treatment through 2-year follow-up

Study Arms (1)

Experimental: Nimotuzumab Combined with Radiotherapy

EXPERIMENTAL

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.

Drug: Nimotuzumab

Interventions

Nimotuzumab DRUG

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

Experimental: Nimotuzumab Combined with Radiotherapy

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ke Hu: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

nimotuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Central Study Contacts

Ke Hu

CONTACT

010-69154011; huk@pumch.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: September 3, 2026
• First Posted: September 15, 2026
• Study Start: September 10, 2026
• Primary Completion (Estimated): June 23, 2027
• Study Completion (Estimated): March 23, 2029
• Last Updated: September 15, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)