Head and Neck Squamous Carcinoma
Conditions
Brief 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
Interventions
RADIATIONSBRT+immunochemotherpy
SBRT radiotherapy，followed with PD-1 monoclonal antibody and TP chemotherapy
PD-1 monoclonal antibody and TP chemotheapy
DRUGcetuximab+immunochemotharpy
PD-1 monoclonal antibody and TP chemotheapy combined with cetuximab
Sponsors
Jiang Feng
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| major pathology response (MPR) | 4-6 weeks after the end of the neoadjuvant therapy | major pathology response |
Countries
China
Contacts
Primary ContactFeng Jiang, MD
Outcome results
None listed