Neoadjuvant Toripalimab + Chemotherapy ± Cetuximab in Locally Advanced Head and Neck Squamous Cell Carcinoma (Neo-ICT)

Inclusion Criteria:

1. Histologically confirmed squamous cell carcinoma of the head and neck (excludingnasopharyngeal cancer);

2. Male or female, aged 18-75 years;

3. Clinical stage III-IVb (AJCC 8th edition TNM stage) and operable patients; iforopharyngeal squamous cell carcinoma (P16-), the stage is III-IVb; if oropharyngealsquamous cell carcinoma (P16+), the stage is III;

4. No prior antitumor therapy including radiotherapy, chemotherapy, immunotherapy orbiological therapy for the current tumor;

5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1;

6. Life expectancy ≥ 6 months;

7. No obvious contraindications to immunotherapy, radiochemotherapy, or surgicaltreatment;

8. Willing to accept surgical treatment;

9. The level of main organ function meets the following criteria:

10. Routine blood tests: WBC ≥ 4.0 × 10^9/L, ANC ≥ 1.5 × 10^9/L, PLT ≥ 100 × 10^9/L, Hb ≥ 90 g/L (no blood transfusion or blood products within 14 days, nocorrection with G-CSF and other hematopoietic growth factors);

11. Biochemical assessments: serum albumin ≥ 3.0 g/dL (30 g/L), TBIL ≤ 1.5 × ULN,ALT, AST ≤ 2.5 × ULN, BUN and CRE ≤ 1.5 × ULN or creatinine clearance ≥ 60mL/min (Cockcroft-Gault formula);

12. Adequate coagulation function: defined as international normalized ratio (INR)or prothrombin time (PT) ≤ 1.5 × ULN; If the subject is receiving anticoagulanttherapy, PT should be within the proposed therapeutic range of theanticoagulant;

13. Women of childbearing potential must have a negative pregnancy test result (serum orurine), conducted within seven days prior to enrollment and agree to use effectivecontraception during the study period and for six months post last dose of anti-PD-1antibody administration. Male subjects with female partners who are capable ofconception must also utilize effective contraception throughout this study durationand for six months after their final dose anti-PD-1 antibody;

14. Willingness to participate in this study by signing an informed consent form, whileexhibiting strong compliance and readiness to cooperate with follow-up procedures.

Exclusion Criteria:

1. Previous treatment with anti-PD-1/PD-L1 antibody, anti-PD-L2 antibody, anti-CD137antibody, anti-CTLA-4 antibody, or other drugs/antibodies targeting T cellco-stimulation or checkpoint pathway;

2. Active autoimmune disease. Subjects in stable condition who do not require systemicimmunosuppressive therapy are permitted; examples include type I diabetes mellitus,hypothyroidism requiring only hormone replacement therapy, and skin conditions thatdo not necessitate systemic treatment (e.g., vitiligo, psoriasis, alopecia).

3. Patients with congenital or acquired immunodeficiency (e.g., HIV infection), activehepatitis B (HBV-DNA ≥ 10^4 copies/ml) or hepatitis C (positive antibody for HCV,and HCV-RNA above the lower limit of detection of the analytical procedure);

4. Known allergy to the study drug or any of its excipients; or serious allergicreaction to other monoclonal antibodies.

5. The occurrence of any of the following conditions within 6 months prior torandomization: myocardial infarction, severe/unstable angina pectoris, NYHA class IIor higher cardiac insufficiency, clinically significant supraventricular orventricular arrhythmias, and symptomatic congestive heart failure.

6. Vaccination with live vaccines within 4 weeks prior to the first dose of the studydrug. Inactivated virus vaccine can be administered for seasonal flu, but notattenuated live influenza vaccines administered intranasally.

7. Known history of allogeneic organ transplant or allogeneic stem cell transplant.

8. The history of drug addiction and the abuse of psychoactive substances.

9. Pregnant or breastfeeding women.

10. Any other malignant neoplasm diagnosed within 5 years prior to study entry, exceptfor carcinoma that is amenable to local treatment and has been cured, such as basalcell carcinoma or squamous cell carcinoma of the skin, superficial bladder cancer,cervical carcinoma in situ, carcinoma in situ of breast ductal, and papillarythyroid cancer.

11. Patients with other significant physical or mental health conditions, or laboratorytest abnormalities that may elevate the risk of participation in the study orcompromise the integrity of the study results, as determined by the investigators,are deemed unsuitable for participation in this study.