Clinical trial

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

Name
11235794
Description
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.
Trial arms
Trial start
2023-10-01
Estimated PCD
2026-12-31
Trial end
2026-12-31
Status
Recruiting
Phase
Early phase I
Treatment
SBRT+immunochemotherpy
SBRT radiotherapy,followed with PD-1 monoclonal antibody and TP chemotherapy
Arms:
experimental
Other names:
immunochemotherapy
Immunochemotherapy
PD-1 monoclonal antibody and TP chemotheapy
Arms:
control
cetuximab+immunochemotharpy
PD-1 monoclonal antibody and TP chemotheapy combined with cetuximab
Arms:
Cetuximab+immunochemo
Size
81
Primary endpoint
major pathology response (MPR)
4-6 weeks after the end of the neoadjuvant therapy
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 81, 'type': 'ESTIMATED'}}
Updated at
2024-03-12

1 organization

2 products

1 indication

Organization
Jiang Feng