Neoadjuvant PD-1 Inhibitor Combined With Cetuximab and Platinum in Resectable Locally Advanced Hypopharyngeal Carcinoma

Inclusion Criteria:

* Pathologically confirmed as hypopharyngeal squamous cell carcinoma;
* Age between 18-75 years;
* Patients with resectable locally advanced hypopharyngeal cancer with T3-4aN0-3bM0 (AJCC 8th) require total laryngectomy;
* Have at least one evaluable target lesion according to RECIST 1.1 criteria.
* No previous treatment for hypopharyngeal carcinoma;
* Satisfactory performance status: ECOG (Eastern Cooperative Oncology Group) scale 0-1;
* Estimated survival ≥ 6 months;
* Normal organ function;
* HBV DNA \< 500 IU/mL (or 2500 copies/mL) and HCV RNA negative;
* Signed informed consent;
* Patients who are compliant, willing, and able to follow visiting schedules, treatment plans, laboratory tests, and other research procedures.
* Male and no pregnant female; able to use the contraceptive method during treatment.

Exclusion Criteria:

* Have a history of other cancers in the past five years, except for the following cancers that are cured in the past five years: basal cell carcinoma and squamous cell carcinoma of the skin, early prostate cancer, papillary thyroid cancer, breast ductal carcinoma in situ and cervix carcinoma in situ;
* The target lesion has been treated with radiation therapy or surgery, except for biopsy to confirm the diagnosis of hypopharyngeal carcinoma;
* Previous chemotherapy, immunotherapy, or bio-targeted therapy for the primary tumor;
* Patients who have participated in other clinical trials within four weeks before the trial;
* Any of the following diseases within six months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass grafting, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, or symptomatic pulmonary embolism.
* Those with hypertension who cannot be reduced to normal range by antihypertensive drugs (systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg).
* Patients with grade I or above coronary heart disease, arrhythmia (including QTc interval prolongation \> 450 ms for men and \> 470 ms for women), and cardiac insufficiency.
* Patients with positive urine protein (urine protein test 2 + or above, or 24-hour urine protein quantification \>1.0g).
* Patients with severe allergic history or allergic constitution; an active autoimmune disease that may worsen when receiving immunostimulants. Patients with type I diabetes, vitiligo, psoriasis, or diseases of hypothyroidism or hyperthyroidism that do not require immunosuppressive therapy are eligible to participate in the study.
* Subjects requiring systemic therapy with corticosteroids (\> 10 mg prednisone or equivalent) or other immunosuppressants within two weeks before the first use of the study drug.
* Previously diagnosed immunodeficiency or known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) - related disease. hepatitis B virus (HBV) surface antigen positive and HBV-DNA ≥ 500 IU/mL (or 2500 copies/mL), or HCV RNA positive. History of active or previous tuberculosis (TB).
* Patients with a history of psychotropic substance abuse who cannot quit or have mental disorders.
* Vaccination within four weeks before enrollment, except for inactivated vaccine.
* Pregnant or lactating women, those who are in the reproductive period and do not use effective contraception;
* Those whom the investigator deems unsuitable to participate in this trial, such as severe acute or chronic medical conditions (including immune colitis, inflammatory bowel disease, non-infectious pneumonia, pulmonary fibrosis) or psychiatric illness (including recent or active suicidal ideation or behavior) or abnormal laboratory tests.