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

Inclusion criteria

• Pathologically confirmed, initially treated, surgically resectable head and neck squamous cell carcinoma.
• Clinical stage III to IVB (AJCC 8th edition), except HPV-positive oropharyngeal cancer
• Following multidisciplinary discussions involving otolaryngologists and radiation oncologists, the assessment concluded that the tumor is resectable or marginally resectable 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 diagnostic biopsies of primary and regional lymph nodes
• Previous chemotherapy for any reason, or radiotherapy in the head and neck area, or molecular 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 T cell 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 with hypertension (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg) who cannot be reduced to the normal range by antihypertensive drugs have grade I or above myocardial ischemia or myocardial infarction, arrhythmia, and grade II cardiac insufficiency; 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 receiving thrombolytic or anticoagulant therapy; Have a definite bleeding tendency; Patients with positive urinary protein (urinary protein test 2+ or more, or 24-hour urinary protein quantification >1.0g)
• Glucocorticoid therapy for 30 days prior to initial administration (prednisone equivalent dose > 10mg daily); Have an active autoimmune disease that has required systemic treatment (i.e., disease-modulating drugs, corticosteroids, or immunosuppressive drugs) in the last 2 years
• History of non-infectious pneumonia requiring corticosteroid treatment within 1 year prior to the first dose administration or current presence of interstitial lung disease
• Active infections such as tuberculosis that require systemic treatment
• A known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive)
• Untreated active hepatitis B; Note: Hepatitis B subjects who met the following criteria 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 to avoid viral reactivation throughout study chemotherapeutic therapy. Subjects with anti-HBC (+), HBsAg (-), anti-HBS (-) and HBV viral load (-) do not need to receive prophylactic anti-HBV therapy, but need to closely monitor viral reactivation. Active HCV-infected subjects (HCV antibody positive and HCV-RNA levels above the lower limit of detection)
• Patients who have a history of psychotropic substance abuse and cannot abstain or have mental disorders
• The investigator determines other circumstances that may affect the conduct of the clinical study and the determination of the study results
• While participating in another therapeutic clinical study