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Tislelizumab + Chemo vs Surgery in HNSCC
NCT06323369Phase 2
Key facts
- Status
- Recruiting
- Start
- Mar 2024
- Primary completion
- Mar 2029
- Countries
- 1
- Sponsor
- Sun Yat-sen Memorial Hospital
- Modality
- Monoclonal Antibodies
- Drugs
- tislelizumab
- Conditions
- head and neck squamous cell carcinoma (HNSCC)
01
Overview
Phase 2, randomised, open-label trial of tislelizumab in head and neck squamous cell carcinoma (HNSCC) (2 arms), sponsored by Sun Yat-sen Memorial Hospital. Primary endpoints: Disease-Free Survival at 3 years and Lymph node positivity rate. Started Mar 2024; status: recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
Neoadjuvant Tislelizumab + Chemotherapy
Neoadjuvant Tislelizumab + Chemo -> Surgery -> Adjuvant Tislelizumab (+/- CRT)
Up-front Surgery
Surgery -> Adjuvant CRT (if node positive) or Follow-up
03
Who it enrols
Patients with resectable, clinically node-negative (stage III/IVA) HNSCC, ECOG 0-1, and no prior immune checkpoint inhibitor therapy.
04
Endpoints
Primary
Disease-Free Survival
Lymph node positivity rate
Secondary
Percentage of Participants Who Experienced High-Grade Adverse Events
Pathological Complete Response rate
Major Pathological Response rate
Lymph node division
Event-free Survival
Overall Survival
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