Nimotuzumab Combined With Immunotherapy and Chemotherapy in the Treatment of Locally Advanced Head and Neck Squamous Cell Carcinoma

Prior treatment

• Participation in another interventional clinical trial within 30 days prior to screening.
• In the investigator's judgment, the patient cannot tolerate or has contraindications to platinum-based chemotherapy (cisplatin or carboplatin) as specified in the protocol.
• Underwent major surgery within 90 days prior to the first study drug, or planning major surgery unrelated to this cancer treatment.
• Receipt of a live vaccine within 30 days before the first study drug administration.

Other illness

• Unresectable disease, poor medical condition for surgery, refusal of surgery for any reason, or excessive tumor burden precluding resection.
• History of other malignancy within the past 5 years (except cured basal cell carcinoma of the skin).
• History of primary immunodeficiency disease.
• Presence of uncontrolled comorbidities, including heart failure, severe pulmonary disease, severe hepatic disease, psychiatric disorders, etc.
• Known HIV infection, active viral hepatitis, or active tuberculosis.
• Hypersensitivity to any study drug or their components.

Lab values

• Received PD-1 inhibitors, EGFR monoclonal antibodies, EGFR-TKIs, or anti-angiogenic agents within 4 weeks prior to enrollment.
• Pregnant (confirmed by serum or urine HCG test) or lactating woman; or subject of childbearing potential unwilling or unable to use effective contraception during study treatment and for at least 6 months after the last dose of study treatment (applicable to both males and females).

Other

• Investigator considers the subject not suitable for study participation.
• Unwilling to participate or unable to provide written informed consent.

• Age 18 to 75 years inclusive.
• Histologically or cytologically confirmed squamous cell carcinoma of the head and neck (HNSCC) (oral cavity, oropharynx, larynx, hypopharynx), stage III-IVB per AJCC 8th edition.
• Resectable disease assessed by a multidisciplinary team (MDT) including surgical, radiological, and pathological specialists.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
• For oropharyngeal carcinoma: mandatory p16 immunohistochemistry (testing within standard of care is acceptable; repeat testing not required). p16 testing is not required for other tumor locations.
• Availability of tumor tissue (archived or newly obtained) for PD-L1 testing (prior testing is acceptable; repeat testing not required).
• At least one measurable lesion per RECIST 1.1.
• Life expectancy ≥ 6 months.
• Adequate hematologic function:
  • White blood cell count ≥ 4.0 × 10⁹/L Absolute neutrophil count ≥ 1.5 × 10⁹/L Platelet count ≥ 100 × 10⁹/L Hemoglobin ≥ 90 g/L
• Adequate renal function:
  • Serum creatinine ≤ 1.5 × upper limit of normal (ULN) OR
  • Creatinine clearance (CrCl) ≥ 60 mL/min calculated by Cockcroft-Gault formula:
  • Female: CrCl (mL/min) = (140 - age) × body weight (kg) × 0.85 / (72 × serum creatinine (mg/dL)) Male: CrCl (mL/min) = (140 - age) × body weight (kg) × 1.00 / (72 × serum creatinine (mg/dL))
• Adequate hepatic function:
  • Total bilirubin ≤ 1.5 × ULN Aspartate aminotransferase (AST) ≤ 2.5 × ULN Alanine aminotransferase (ALT) ≤ 2.5 × ULN
• Female subjects: negative pregnancy test within 2 weeks before first study drug, non-lactating.
  • Females: highly effective contraception required during study and for 6 months after last study drug.
  • Males: highly effective contraception required during study and for 6 months after last study drug.
• Written informed consent obtained prior to any study-specific procedures, and willingness to comply with all study visits and protocol requirements.