A multicenter, randomized, controlled, open-label, Phase II/III clinical trial designed to evaluate the efficacy and safety of postoperative radiotherapy combined with Nimotuzumab,with or without Bemcentinib, in postoperative head and neck squamouscell cancer patients with intermediate-risk pathological factor. The primary endpoint is the 3-year disease-freesurvival (DFS). A total of 193 patients will be enrolled in both the experimental and control groups, resulting in a total planned enrollment of 386 patients.
Age ≥ 18 years
ECOG performance status: 0-2
Histologically confirmed squamous cell carcinoma of the head and neck (oral cavity, oropharynx, larynx); oropharyngeal cancer must be p16-negative (p16 positivity defined as ≥70% staining)
Expected survival time ≥ 6 months;
Pregnancy or lactation, or intention to become pregnant during the study period.
Presence of active autoimmune disease or immunodeficiency, including but not limited to: myasthenia gravis, interstitial pneumonia, enteritis, autoimmune hepatitis, hypophysitis, vasculitis, nephritis, or hyperthyroidism.
Known human immunodeficiency virus (HIV) infection, history of autoimmune diseases, or history of organ transplantation.
Use of systemic immunosuppressive drugs within 2 weeks prior to initiation of study treatment, or anticipated need for systemic immunosuppressive therapy during the study treatment period.