NCT06323369

Tislelizumab Combined With Chemotherapy Followed by Surgery Versus Up-front Surgery in Resectable Clinically Node-negative Head and Neck Squamous Cell Carcinoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 154 (estimated)
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Head and Neck Squamous Cell Carcinoma

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）	Cisplatin AUC=5 administered by intravenous (IV) infusion on Day 1 of each 21-day cycle
DRUG	Carboplatin（adjuvant）	Cisplatin AUC=5 administered by intravenous (IV) infusion on Day 1 of each 21-day cycle

Timeline

• Start date: 2024-03-25
• Primary completion: 2029-03-25
• Completion: 2029-09-25
• First posted: 2024-03-21
• Last updated: 2024-05-17

Locations

1 site across 1 country: China