NCT06235918

Neoadjuvant Tislelizumab Plus Chemotherapy for Resectable Locally-advanced Head and Neck Squamous Cell Carcinoma

Neoadjuvant Tislelizumab (BGB-A317, Anti-PD-1 Antibody) Plus Nab-Paclitaxel and Carboplatin for Resectable Locally-advanced Head and Neck Squamous Cell Carcinoma : A Single-arm, Phase II Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Xiang Lu · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

For resectable squamous cell carcinoma of the head and neck , novel therapeutic approaches are still needed to improve outcomes. Neoadjuvant immunochemotherapy is considered as a potentially effective strategy. The purpose of this study is to evaluate the safety and efficacy of neoadjuvant of tislelizumab combined with platinum doublet for resectable locally-advanced head and neck squamous-cell carcinoma .

Conditions

• Head and Neck Squamous Cell Carcinomas
• Resectable Head and Neck Squamous-cell Carcinoma

Interventions

Type	Name	Description
DRUG	Tislelizumab	Tislelizumab: 200mg,administered via Intravenous (IV) injection, day 1 of each 21-day cycle, neoadjuvant therapy : 2 cycles
DRUG	Nab-paclitaxel	260mg/m\^2, IV, day 1 of each 21-day cycle, neoadjuvant therapy : 2 cycles
DRUG	Carboplatin	AUC 5 mg/mL/min by IV infusion once every 3 weeks,day 1 of each 21-day cycle,neoadjuvant therapy : 2 cycles

Timeline

• Start date: 2023-01-01
• Primary completion: 2025-01-01
• Completion: 2026-01-01
• First posted: 2024-02-01
• Last updated: 2024-02-01

Locations

1 site across 1 country: China