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

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

This study is testing if combining a new immune therapy with radiation and chemotherapy can help people with advanced head and neck cancer do better before surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 81 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Zhejiang Cancer Hospital (Academic / other)
• Drugs / interventions: radiation, prednisone, chemotherapy, immunotherapy, certuxmab
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT06306846 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with pathologically confirmed localized advanced HNSCC who are eligible for surgical resection.

Not a fit: Patients with clinical illnesses that hinder safe participation or those unable to tolerate standard radiotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved survival rates and better quality of life for patients with advanced HNSCC.

How similar studies have performed: While the combination of immunotherapy and chemotherapy has shown promise in other studies, the specific approach of combining SBRT with these therapies in HNSCC is exploratory and may provide novel insights.

Eligibility criteria

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 this trial is running

Hangzhou, Zhejiang

• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: feng Jiang, MD — Zhejiang Cancer Hospital
• Study coordinator: Feng Jiang, MD

Conditions Head and Neck Squamous Carcinoma