Combining SBRT with immunotherapy and chemotherapy for advanced head and neck cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness and safety of combining a PD-1 monoclonal antibody with neoadjuvant stereotactic body radiation therapy (SBRT) and chemotherapy in patients with localized advanced head and neck squamous cell carcinoma (HNSCC). Participants will receive these treatments before surgical resection, with the aim of improving the pathological response rates and overall prognosis. The study also explores the potential for enhanced anti-tumor immune effects through the release of specific antigens following radiotherapy. By evaluating the outcomes of this triple therapy approach, the study seeks to provide insights into more effective treatment strategies for HNSCC.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Pathologically confirmed initially resectable Localized advanced head and neck squamous cell carcinoma，and plan for surgical resection.
2. Immunohistochemical confirmed the HPV status through P16 immunostaining.
3. Male or female, Between the aged from 18 to 70 years,
4. Able to provide informed consent, comply with agreements, and sign research specific consent documents.
5. ZPS is less than 2.
6. Adequate bone marrow, liver and kidney, heart , lung and other physiological function determined by Researchers, able to tolerate neoadjuvant anti-PD-1, anti-EGFR, and radiation therapy.
7. Subjects are willing and able to comply with visits, treatment regimens, laboratory tests, and other requirements of the study as spe.

Exclusion Criteria:

1. Any clinical illness, such as hemorrhage, active infection, or mental illness, that can hinder safe participation or adherence of research procedures.
2. Patients who cannot accept radiotherapy in standard treatment.
3. Long term maintenance of oral steroids (≥ 20mg prednisone equivalent per day) is required, excluding patients with inhaled, local, or non absorbable steroids.
4. Autoimmune diseases, including but not limited to inflammatory bowel disease, rheumatoid arthritis, autoimmune hepatitis, systemic sclerosis (scleroderma and variants), systemic lupus erythematosus, autoimmune vasculitis, autoimmune neuropathy (such as Guillain Barre syndrome), etc.

Where it's running

• Zhejiang Cancer Hospital
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Principal investigator: feng Jiang, MD — Zhejiang Cancer Hospital
• Study coordinator: Feng Jiang, MD
• Email: jiangfeng@zjcc.org.cn
• Phone: 0086-571-88128202

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.