Postoperative Radiotherapy Combined With Nimotuzumab Followed by Bemcentinib in High-Risk Patients With Head and Neck Squamous Cell Carcinoma

Inclusion Criteria

• •1. Age ≥ 18 years.
• •2. Patients ineligible for cisplatin chemotherapy, defined as meeting any of the following:① Age \> 70 years;② Renal insufficiency (creatinine clearance \< 50 mL/min; criterion ⑩ below does not apply if this criterion is met);③ Severe tinnitus or hearing impairment (requiring hearing aid, or audiometry showing ≥ 25 dB loss at two consecutive frequencies);④ Unable to receive intravenous hydration (e.g., due to cardiac dysfunction or other comorbidities, as judged by the investigator);⑤ Neuropathy \> Grade 1;⑥ Patient refusal of chemotherapy.
• •3. Histologically confirmed locally advanced head and neck squamous cell carcinoma (AJCC 8th edition Stage III-IVB), including oral cavity cancer, HPV-negative/unrelated oropharyngeal cancer, hypopharyngeal cancer, and laryngeal cancer.
• •4. Underwent radical surgery with at least one high-risk feature:
• •Extracapsular extension (ECE) of lymph node metastasis; Close margin (\< 1 mm) or positive margin;
• •* 4 metastatic lymph nodes, or multiple perineural invasions.
• •5. No evidence of distant metastasis on imaging.
• •6. Sufficient tumor tissue available for EGFR and PD-L1 testing; for oropharyngeal cancer, HPV/p16 testing is required (testing may be waived if results are already available).
• •7. Expected survival ≥ 6 months.
• •8. ECOG performance status 0-1.
• •9. Adequate hematologic function:
• •WBC ≥ 3 × 10⁹/L; ANC ≥ 1.5 × 10⁹/L; Platelets ≥ 100 × 10⁹/L; Hemoglobin ≥ 90 g/L.
• •10. Adequate renal function:Serum creatinine ≤ 1.5 × ULN or creatinine clearance (CrCl) \> 50 mL/min (calculated by Cockcroft-Gault formula):
• •Female: CrCl = (140 - Age) × Weight (kg) × 0.85 / (72 × Scr (mg/dL)) Male: CrCl = (140 - Age) × Weight (kg) × 1.00 / (72 × Scr (mg/dL))
• •11. Adequate hepatic function:
• •Total bilirubin ≤ 1.5 × ULN; AST ≤ 2.5 × ULN; ALT ≤ 2.5 × ULN.
• •12. Women of childbearing potential: negative serum or urine pregnancy test within 14 days before enrollment, and agreement to use effective contraception during the study.Male subjects: use effective contraception from the start of treatment until 180 days after the last study drug administration.
• •13. Voluntary participation in the study, signed written informed consent, good compliance, and willingness to comply with follow-up procedures.