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),
Age ≥18 years.
Histologically confirmed stage III-IVB (AJCC 8th edition) head and neck squamous cell carcinoma (including cancers of the oral cavity, oropharynx, hypopharynx, and larynx).
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).
Suitable for definitive radiotherapy with curative intent.
Receipt of a PD-1 inhibitor, EGFR monoclonal antibody, EGFR-TKI, or anti-angiogenic agent within 4 weeks prior to enrollment.
Participation in another interventional clinical trial within 30 days prior to screening.
History of other malignancy (except cured basal cell carcinoma of the skin).
History of primary immunodeficiency.