NCT06125223

PABLIXIMAB as Neoadjuvant Therapy for Head and Neck Squamous-cell Carcinoma

A Single-arm, Prospective, Phase II Study of PABLIXIMAB Combined With TP Chemotherapy as Neoadjuvant Therapy for Locally Advanced Head and Neck Squamous-cell Carcinoma

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 45 (estimated)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn about the efficacy and safety of pablizumab combined with neoadjuvant chemotherapy in patients with locally advanced head and neck squamous cell carcinoma. The main question it aims to answer is: Pathological complete remission (PCR) rate of tumor after neoadjuvant immunotherapy. Participants will be asked to perform CT and MRI of head and neck, ultrasonography of cervical lymph nodes and necessary laboratory examinations Before and after neoadjuvant therapy. And will be following-up for at least 1 year.

Detailed description

The secondary questions it aims to answer are: Objective response rate (ORR) after neoadjuvant therapy * R0 resection rate * major pathological remission (MPR) rate * organ preservation rate * event-free survival (EFS) * local recurrence-free survival (LRFS) * distant metastasis-free survival (DMFS) * quality of life score (QoL) * overall survival (OS) * incidence of adverse events (including neoadjuvant stage AEs and full course AEs) The exploratory question it aims to answer is: clearance of peripheral blood ctDNA.

Conditions

• Squamous Cell Carcinoma of Head and Neck
• Neoadjuvant Therapy
• Immunotherapy

Timeline

• Start date: 2023-11-01
• Primary completion: 2025-11-01
• Completion: 2026-11-01
• First posted: 2023-11-09
• Last updated: 2023-11-09