RecruitingPhase 2NCT06306846

Neoadjuvant SBRT in Localized Advanced HNSCC

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

Sponsor

Jiang Feng

Enrollment

81 participants

Start Date

Oct 1, 2023

Study Type

INTERVENTIONAL

Conditions

Head and Neck Squamous Carcinoma

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.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether giving a short, precise course of radiation (called stereotactic body radiation therapy, or SBRT) before surgery — along with immunotherapy and a targeted drug — improves outcomes for people with locally advanced head and neck squamous cell cancer that can be surgically removed. **You may be eligible if...** - You are between 18 and 70 years old - You have been confirmed to have locally advanced head and neck squamous cell carcinoma (HNSCC) that is eligible for surgery - Your HPV status has been confirmed - Your performance score (ZPS) is 2 or below - Your heart, lungs, liver, kidneys, and bone marrow function are adequate to tolerate treatment **You may NOT be eligible if...** - Your cancer is not surgically removable - You have serious medical conditions that would interfere with treatment - You are unable to comply with the study's visit schedule and procedures Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

RADIATIONSBRT+immunochemotherpy

SBRT radiotherapy，followed with PD-1 monoclonal antibody and TP chemotherapy

DRUGImmunochemotherapy

PD-1 monoclonal antibody and TP chemotheapy

DRUGcetuximab+immunochemotharpy

PD-1 monoclonal antibody and TP chemotheapy combined with cetuximab

Locations(1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06306846