Neoadjuvant EGFR-ADC Combined With Anti-PD-1 Monoclonal Antibody in Resectable Locally Advanced Hypopharyngeal Squamous Cell Carcinoma

Exclusion Criteria

• •1. Patients with distant metastasis;
• •2. Patients with uncontrolled severe medical conditions;
• •3. Patients with a history of allergy or hypersensitivity to any component of monoclonal antibody therapies;
• •4. Uncontrolled cardiac clinical symptoms or diseases;
• •5. Occurrence of severe infection (CTCAE Grade \> 2) within 4 weeks prior to the first dose of the study drug;
• •6. Unexplained fever \> 38.5°C during the screening period or before the first dose;
• •7. Active autoimmune disease or a history of autoimmune disease;
• •8. History of immunodeficiency, or a history of organ transplantation or allogeneic bone marrow transplantation;
• •9. Patients with untreated chronic hepatitis B, or chronic hepatitis B virus (HBV) DNA exceeding 500 IU/mL, or patients with active hepatitis C virus (HCV) must be excluded;
• •10. History of interstitial lung disease;
• •11. Patients with active pulmonary tuberculosis infection identified by medical history or CT scan;
• •12. Patients who have received any of the following treatments:
• •A. Receipt of any investigational drug or anti-cancer therapy within 4 weeks prior to the first dose of the study drug; B. Requirement for systemic treatment with corticosteroids (daily dose \> 10 mg prednisone equivalent) or other immunosuppressive medications within 2 weeks prior to the first dose of the study drug.; C. Prior vaccination with an anti-tumor vaccine or receipt of a live vaccine within 4 weeks prior to the first dose of the study drug; D. Major surgery or significant traumatic injury within 4 weeks prior to the first dose of the study drug; E. Concurrent enrollment in another clinical study;
• •13. Dementia, altered mental status, or any psychiatric condition that would interfere with understanding or providing informed consent or completing questionnaires;
• •14. Subjects with peripheral neuropathy ≥ Grade 2 according to CTCAE V5.0;
• •15. History of allergy or hypersensitivity to any component of the study treatment;
• •16. History of a primary malignancy other than head and neck squamous cell carcinoma within the previous 5 years;
• •17. Requirement for concurrent treatment with other anti-tumor therapies;
• •18. Patients deemed unsuitable for enrollment by the investigator;
• •19. Pregnant or breastfeeding women.