RecruitingPhase 2NCT06673693

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

Neoadjuvant SBRT Sequential Tislelizumab in Locally Advanced Head and Neck Squamous Cell Carcinoma: A Single-Arm Phase II Clinical Study

Sponsor

Sun Yat-sen University

Enrollment

24 participants

Start Date

Apr 15, 2025

Study Type

INTERVENTIONAL

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

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria10

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
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

Exclusion Criteria10

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)