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OncoMatch/Clinical Trials/NCT05582265

Tislelizumab Combined With Chemotherapy Followed by Surgery Versus Up-front Surgery in Resectable Head and Neck Squamous Cell Carcinoma (REDUCTION-I)

Is NCT05582265 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments for head and neck squamous cell carcinomas.

Phase 3RecruitingSun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityNCT05582265Data as of May 2026

Treatment: Tislelizumab(neoadjuvant) · Cisplatin (neoadjuvant) · Nab-paclitaxel (neoadjuvant) · Cisplatin(adjuvant) · Tislelizumab(adjuvant) · Carboplatin (neoadjuvant) · Carboplatin (adjuvant)A prospective, randomized, open-label, multicenter Phase 3 trial designed to compare the safety and efficacy of Tislelizumab combined with chemotherapy followed by surgery versus up-front surgery in resectable head and neck squamous cell carcinoma.

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Extracted 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

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: immune-mediated therapy (anti-CTLA-4, anti-PD-1, anti-PD-L1, anti-PD-L2)

Exception: therapeutic anticancer vaccines excluded from this restriction

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 anticancer therapy

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 Gilbert Syndrome: < 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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