Tislelizumab Combined With SBRT for the Treatment of Head and Neck Squamous Cell Carcinoma

Inclusion Criteria:

• Pathologically confirmed, initially treated, surgically resectable head and necksquamous cell carcinoma.

• Clinical stage III to IVB (AJCC 8th edition), except HPV-positive oropharyngealcancer

• Following multidisciplinary discussions involving otolaryngologists and radiationoncologists, the assessment concluded that the tumor is resectable or marginallyresectable and suitable for preoperative SBRT

• Karnofsky Performance Status score ≥ 70

• Ages 18 to 70

• The primary organ functions meet the test requirements

• Patients participate voluntarily and sign informed consent forms

Exclusion Criteria:

• Patients previously treated with head and neck surgery were excluded from diagnosticbiopsies of primary and regional lymph nodes

• Previous chemotherapy for any reason, or radiotherapy in the head and neck area, ormolecular targeted drug therapy; Previously received anti-PD-1, anti-PD-L1,anti-PD-L2 and other drugs or drugs acting on another irritating or co-inhibitory Tcell receptor (such as CTLA-4, OX 40, CD137) treatment, or cell biotherapy

• Pregnant or lactating women

• Have had or co-had other malignancies

• The patient also has a serious, uncontrolled illness

• Heart, brain, lung and other important organ function abnormal. Patients withhypertension (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg)who cannot be reduced to the normal range by antihypertensive drugs have grade I orabove myocardial ischemia or myocardial infarction, arrhythmia, and grade II cardiacinsufficiency; Abnormal coagulation function (INR >1.5 or prothrombin time (PT) >ULN+4 seconds or APTT >1.5 ULN), have a tendency to bleed or are receivingthrombolytic or anticoagulant therapy; Have a definite bleeding tendency; Patientswith positive urinary protein (urinary protein test 2+ or more, or 24-hour urinaryprotein quantification >1.0g)

• Glucocorticoid therapy for 30 days prior to initial administration (prednisoneequivalent dose > 10mg daily); Have an active autoimmune disease that has requiredsystemic treatment (i.e., disease-modulating drugs, corticosteroids, orimmunosuppressive drugs) in the last 2 years

• History of non-infectious pneumonia requiring corticosteroid treatment within 1 yearprior to the first dose administration or current presence of interstitial lungdisease

• Active infections such as tuberculosis that require systemic treatment

• A known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2antibody positive)

• Untreated active hepatitis B; Note: Hepatitis B subjects who met the followingcriteria were also eligible for inclusion: HBV viral load must be <1000 copies /ml (200 IU/ml) prior to initial dosing, and subjects should receive anti-HBV therapy toavoid viral reactivation throughout study chemotherapeutic therapy. Subjects withanti-HBC (+), HBsAg (-), anti-HBS (-) and HBV viral load (-) do not need to receiveprophylactic anti-HBV therapy, but need to closely monitor viral reactivation.Active HCV-infected subjects (HCV antibody positive and HCV-RNA levels above thelower limit of detection)

• Patients who have a history of psychotropic substance abuse and cannot abstain orhave mental disorders

• The investigator determines other circumstances that may affect the conduct of theclinical study and the determination of the study results

• While participating in another therapeutic clinical study