tislelizumab combined with sbrt for the treatment of head and neck squamous cell carcinoma

Conditions: Head and Neck Squamous Cell Carcinoma (HNSCC); HNSCC

Summary: exploring the efficacy and safety of tislelizumab combined with stereotactic body radiation therapy (sbrt) as neoadjuvant treatment for locally advanced head and neck squamous cell carcinoma (hnscc).


Eligibility criteria:
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

Keywords: sbrt pd-1 antibody tislelizumab neoadjuvant therapy