OncoMatch/Clinical Trials/NCT06323369
Tislelizumab Combined With Chemotherapy Followed by Surgery Versus Up-front Surgery in Resectable Clinically Node-negative Head and Neck Squamous Cell Carcinoma
Is NCT06323369 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for head and neck squamous cell carcinoma.
Treatment: Tislelizumab（neoadjuvant） · Cisplatin （neoadjuvant） · Nab-paclitaxel （neoadjuvant） · Cisplatin（adjuvant） · Tislelizumab（adjuvant） · Carboplatin（neoadjuvant） · Carboplatin（adjuvant） — A prospective, randomized, open-label, multicenter Phase 2 trial designed to compare the efficacy and safety of Tislelizumab combined with chemotherapy followed by surgery versus up-front surgery in resectable clinically node-negative head and neck squamous cell carcinoma.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Disease stage
Required: Stage III, IVA
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: immune-mediated therapy (anti-CTLA-4, anti-PD-1, anti-PD-L1, anti-PD-L2, other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways)
Exception: excluding therapeutic anticancer vaccines
no prior exposure to immune-mediated therapy, including anti- cytotoxic T-lymphocyte protein 4 (CTLA-4), anti-programmed cell death 1, anti-programmed cell death 1 ligand 1 (PD-L1), or anti-programmed cell death ligand 2 antibodies, excluding therapeutic anticancer vaccines
Cannot have received: investigational agent
currently participating in or has participated in a study of an investigational agent within 4 weeks of the first dose of treatment
Cannot have received: systemic therapy, surgery, or radiation for another malignancy
has had another known invasive malignancy within the previous 5 years and/or has had surgery, chemotherapy, targeted small molecule therapy or radiation therapy within 5 years for a known malignancy prior to study day 0
Lab requirements
Blood counts
Absolute Neutrophil Count >1,500/µL; Platelets > 100 X 10^3/µL; Hemoglobin > 9.0 g/dL
Kidney function
Serum creatinine < 1.5 X ULN or CrCl > 40mL/min
Liver function
AST/ALT ≤ 3 x ULN; Total Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL)
Adequate hepatic and renal function as demonstrated by...AST/ALT ≤ 3 x ULN Total Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL)...Serum creatinine < 1.5 X ULN or CrCl > 40mL/min...Adequate bone marrow function as demonstrated by: Absolute Neutrophil Count >1,500/µL Platelets > 100 X 10^3/µL Hemoglobin > 9.0 g/dL
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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