SBRT+immunochemotherpy: SBRT radiotherapy，followed with PD-1 monoclonal antibody and TP chemotherapy
Immunochemotherapy: PD-1 monoclonal antibody and TP chemotheapy
cetuximab+immunochemotharpy: PD-1 monoclonal antibody and TP chemotheapy combined with cetuximab
Study 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
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
major pathology response (MPR) — 4-6 weeks after the end of the neoadjuvant therapy major pathology response
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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