NCT07055841

Single-Arm Exploratory Study of PD-L1 Antibody Plus Neoadjuvant Chemotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 69 (estimated)
• Sponsor: Xiuping Ding · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This single-arm exploratory study plans to enroll 69 locally advanced head and neck squamous cell carcinoma (LA-HNSCC) patients. Participants will receive Adebrelimab (PD-L1 antibody) plus TP regimen (docetaxel/cisplatin) as neoadjuvant therapy for 1-4 weeks, followed by surgery and subsequent follow-up phase.

Conditions

• Squamous Cell Carcinoma of Head and Neck

Interventions

Type	Name	Description
DRUG	Adebrelimab	1200mg, intravenous infusion, D1， Every three weeks, there are two cycles in total.
DRUG	TP regimen	TP regimen: Docetaxel 75 mg/m2, intravenous infusion, D1， Cisplatin 75 mg/m2, intravenous infusion, D1， Every three weeks, there are two cycles in total.
PROCEDURE	Surgery or radiotherapy	Surgery or radiotherapy should be performed 1-4 weeks after the completion of neoadjuvant therapy.

Timeline

• Start date: 2023-04-01
• Primary completion: 2025-08-01
• Completion: 2026-08-01
• First posted: 2025-07-09
• Last updated: 2025-07-09

Locations

1 site across 1 country: China