Actively Recruiting

Phase 2
Age: 18Years - 70Years
All Genders
NCT06673693

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

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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