NCT05582265

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 537 (estimated)
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Head and Neck Squamous Cell Carcinomas

Interventions

Type	Name	Description
DRUG	Tislelizumab（neoadjuvant）	Tislelizumab 200 mg administered by intravenous (IV) infusion on Day 1 of each 21-day cycle
DRUG	Cisplatin （neoadjuvant）	Cisplatin 75 mg/m2 administered by intravenous (IV) infusion on Day 1 of each 21-day cycle
DRUG	Nab-paclitaxel （neoadjuvant）	Nab-paclitaxel 260mg/m2 administered by intravenous (IV) infusion on Day 1 of each 21-day cycle
PROCEDURE	Surgical resection	Standard of care
DRUG	Cisplatin（adjuvant）	Cisplatin 100 mg/m2 administered by intravenous (IV) infusion on Day 1 of each 21-day cycle
DRUG	Tislelizumab（adjuvant）	Tislelizumab 200 mg administered by intravenous (IV) infusion on Day 1 of each 21-day cycle
RADIATION	Radiation	Recommended, standard of care
DRUG	Carboplatin (neoadjuvant）	Carboplatin (IV), AUC=5，administered by intravenous (IV) infusion on Day 1 of each 21-day cycle
DRUG	Carboplatin (adjuvant）	Carboplatin (IV), AUC=5，administered by intravenous (IV) infusion on Day 1 of each 21-day cycle

Timeline

• Start date: 2022-10-28
• Primary completion: 2028-10-01
• Completion: 2030-10-01
• First posted: 2022-10-17
• Last updated: 2024-05-17

Locations

3 sites across 1 country: China