NCT06699498

Neoadjuvant Therapy of Targeted Immunotherapy Combined With Chemotherapy for Locally Advanced HNSCC

Phase II Clinical Study of Neoadjuvant Therapy With Benmelstobart Combined With Anlotinib and Chemotherapy for Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Exploring the safety and effectiveness of neoadjuvant therapy using benmelstobart combined with anlotinib and chemotherapy for locally advanced squamous cell carcinoma of the head and neck patients.

Detailed description

This is a single-center, Phase II study designed to treat patients with stage III/IVa head and neck squamous cell carcinoma who meet the inclusion and exclusion criteria. The neoadjuvant therapy involves the administration of benmelstobart combined with anlotinib and chemotherapy for three cycles (21 days per cycle). Surgical resection will be performed within 2 weeks after the completion of neoadjuvant therapy. Tumor tissue samples and blood samples will be collected post-surgery for ctDNA detection. If the post-surgical ctDNA test result is positive, the patient will receive standard adjuvant therapy combined with benmelstobart, along with benmelstobart maintenance therapy. If the result is negative, the patient will receive standard adjuvant therapy alone.

Conditions

• Head and Neck Squamous Cell Carcinoma
• Neoadjuvant Therapy
• PD-L1
• Anlotinib

Interventions

Type	Name	Description
DRUG	Benmelstobart	1200mg, D1, IV,q3w
DRUG	Anlotinib	10mg，D1-14，po，q3w
DRUG	Cisplatin	60mg/m2， D1， IV，q3w
DRUG	Paclitaxel for Injection （Albumin Bound）	260mg/m2，IVgtt ，D1，q3w

Timeline

• Start date: 2024-12-03
• Primary completion: 2025-12-01
• Completion: 2027-12-01
• First posted: 2024-11-21
• Last updated: 2024-11-21

Locations

1 site across 1 country: China