Neoadjuvant Radiotherapy Combined With Toripalimab for Locally Advanced Head and Neck Squamous Cell Carcinoma

Inclusion Criteria:

• Sign informed consent;
• Age ≥ 18 years, regardless of gender;
• Histology or cytology confirmed head and neck squamous cell carcinoma, HNSCC (Oralcavity, oropharynx, larynx and hypopharynx), and previously untreated;
• Imaging confirmed that HNSCC was locally advanced and operable;
• Imaging confirmed no metastasis;
• ECOG physical status score 0-1;
• Life expectancy at least 24 weeks;
• Have measurable lesions;
• Good function of other major organs (liver, kidney, blood system, etc.): Absolute neutrophil count ((ANC) ≥ 1.0×10^9), platelet (≥ 80×10^9), hemoglobin (≥ 80g/L).Blood biochemical examination must meet: serum creatinine (Cr) ≤1.5 times the upper limitof normal (ULN) or endogenous creatinine clearance ≥60mL/min; TBIL≤1.5×ULN; ALB≥30g/L; ALTand AST≤ 3.0×ULN; TSH≤1.5×ULN;
• Female patients with fertility must undergo a pregnancy test (serum or urine) within 14 days before enrollment, and the result is negative, and they voluntarily adoptappropriate methods of contraception during the observation period and within 120 daysafter the last administration; Male patients must voluntarily take effectivecontraceptive measures from the start of treatment until 120 days after the lastadministration.

Exclusion Criteria:

• Pregnant or breastfeeding, or planning to become pregnant during the study period
• Patients with active autoimmune diseases or immunodeficiency diseases, including butnot limited to myasthenia gravis, interstitial pneumonia, enteritis, autoimmunehepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, positive HIV test ora history of the above diseases, or a history of organ transplantation;
• Receiving systemic immunosuppressive drugs within 2 weeks before starting studytreatment, or anticipating the need for systemic immunosuppressive drugs during studytreatment;
• Received systemic immunostimulants (including but not limited to interferon orinterleukin-2 [IL-2]) within 4 weeks before starting study treatment;
• History of other malignant tumors within the past 5 years, except cured cervicalcarcinoma in situ, non-melanoma skin cancer, localized prostate cancer, ductalcarcinoma in situ;
• Serious cardiovascular disease, unstable arrhythmia, or unstable angina pectoriswithin 3 months before starting study treatment;
• The subject has an active infection or infectious disease, or unexplained fever (bodytemperature > 38.5℃) during screening and before the first dose;
• Patients who have received therapeutic oral or intravenous antibiotics within 2 weeksprior to starting study treatment; patients receiving prophylactic antibiotic therapy (e.g., prophylaxis for urinary tract infection or chronic obstructive pulmonary -Untreated active hepatitis;
• Receiving immunotherapy such as PD-1/L1 antibody or CTLA-4 antibody within 4 weeksbefore enrollment;
• Received chemotherapy or targeted therapy within 4 weeks before enrollment;
• The subject has participated in or completed other clinical trials within 4 weeksbefore enrollment;
• Subjects may need to receive other anti-tumor therapy during the study;
• Subjects may need to receive a vaccine during the study or within 4 weeks prior toenrollment.