Tislelizumab Combined With Chemotherapy Followed by Surgery Versus Up-front Surgery in Resectable Head and Neck Squamous Cell Carcinoma (REDUCTION-I)
A Phase 3, Prospective,Multicenter, Randomized Open-Label Trial to Compare the Efficacy and Safety of Tislelizumab (BGB A317, Anti-PD1 Antibody) Combined With Chemotherapy Followed By Surgery Versus Up-Front Surgery as Treatment for Resectable Head And Neck Squamous Cell Carcinoma
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
537 participants
Oct 28, 2022
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
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Interventions
Tislelizumab 200 mg administered by intravenous (IV) infusion on Day 1 of each 21-day cycle
Cisplatin 75 mg/m2 administered by intravenous (IV) infusion on Day 1 of each 21-day cycle
Nab-paclitaxel 260mg/m2 administered by intravenous (IV) infusion on Day 1 of each 21-day cycle
Standard of care
Cisplatin 100 mg/m2 administered by intravenous (IV) infusion on Day 1 of each 21-day cycle
Tislelizumab 200 mg administered by intravenous (IV) infusion on Day 1 of each 21-day cycle
Recommended, standard of care
Carboplatin (IV), AUC=5,administered by intravenous (IV) infusion on Day 1 of each 21-day cycle
Carboplatin (IV), AUC=5,administered by intravenous (IV) infusion on Day 1 of each 21-day cycle
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05582265