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 (Jun 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
Treatments studied
Chemotherapy
Other
Cancer type
Head and Neck Squamous Cell Carcinoma
Disease stage
Required: Stage III, IVA
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
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.
Frequently asked questions
Is NCT06323369 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
What disease stage is eligible?
Stage III or IVA is required.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages