Actively Recruiting
Tislelizumab Combined With SBRT for the Treatment of Head and Neck Squamous Cell Carcinoma
Led by Sun Yat-sen University · Updated on 2025-04-16
24
Participants Needed
2
Research Sites
245 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Tislelizumab Combined With SBRT for the Treatment of Head and Neck Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Tumor assessed as resectable or marginally resectable and suitable for preoperative SBRT after multidisciplinary discussion
- Karnofsky Performance Status score 60 70
- Age between 18 and 70 years
- Primary organ functions meet test requirements
- Patients voluntarily participate and sign informed consent forms
You will not qualify if you...
- Previous head and neck surgery excluding diagnostic biopsies of primary and regional lymph nodes
- Prior chemotherapy, head and neck radiotherapy, molecular targeted therapy, or immunotherapy targeting PD-1, PD-L1, PD-L2, CTLA-4, OX 40, CD137, or cell biotherapy
- Pregnant or lactating women
- History or concurrent other malignancies
- Serious uncontrolled illnesses
- Abnormal heart, brain, lung, or other important organ functions including uncontrolled hypertension, myocardial ischemia, infarction, arrhythmia, cardiac insufficiency, abnormal coagulation, bleeding tendencies, or positive urinary protein
- Glucocorticoid therapy exceeding prednisone 10 mg daily within 30 days prior
- Active autoimmune diseases requiring systemic treatment in the past 2 years
- History of non-infectious pneumonia requiring corticosteroids within 1 year or current interstitial lung disease
- Active infections such as tuberculosis requiring systemic treatment
- Known HIV infection
- Untreated active hepatitis B or active hepatitis C infection
- History of psychotropic substance abuse or mental disorders
- Other conditions affecting study conduct or results as determined by the investigator
- Participation in another therapeutic clinical study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Not Yet Recruiting
2
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
C
Chun-Yan Chen
CONTACT
Y
Ya-Ni Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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