NCT06306846

Neoadjuvant SBRT in Localized Advanced HNSCC

Neoadjuvant Stereotactic Body Radiotherapy（SBRT）Combined With Immunotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 81 (estimated)
• Sponsor: Jiang Feng · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The response rate of HNSCC to immune checkpoint blockade was not satisfied. Improving the mPR rate of neoadjuvant immunotherapy through the combination with other treatment methods is an important way to further improve the prognosis of such patients. This study aims to explore the efficacy and safety of PD-1 monoclonal antibody with neoadjvant SBRT and chemotherapy. The triple mode not only can Increase the effectiveness of neoadjuvant therapy，meanwhile，the in situ tumor vaccine inoculation effect generated by enhancing the release of specific antigens after tumor radiotherapy with PD-1 monoclonal antibody achieves a sustained anti-tumor immune effect throughout the body， reducing postoperative adjuvant radiotherapy and chemotherapy. The triple mode has important exploratory value in achieving high quality and long-term survival for patients, and may provides a more efficient mode for locally advanced HNSCC.

Detailed description

locally advanced HNSCC patients would receive PD-1 antibody and chemotherapy with or without SBRT covering GTV of primary disease and metastatic nodes , followed by surgery. pathological response was measured .Neoadjuvant PD-1 antibody and chemotherapy with certuxmab was also tested

Conditions

• Head and Neck Squamous Carcinoma

Interventions

Type	Name	Description
RADIATION	SBRT+immunochemotherpy	SBRT radiotherapy，followed with PD-1 monoclonal antibody and TP chemotherapy
DRUG	Immunochemotherapy	PD-1 monoclonal antibody and TP chemotheapy
DRUG	cetuximab+immunochemotharpy	PD-1 monoclonal antibody and TP chemotheapy combined with cetuximab

Timeline

• Start date: 2023-10-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2024-03-12
• Last updated: 2024-03-12

Locations

1 site across 1 country: China