Actively Recruiting
Neoadjuvant SBRT in Localized Advanced HNSCC
Led by Jiang Feng · Updated on 2024-03-12
81
Participants Needed
1
Research Sites
169 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Neoadjuvant SBRT in Localized Advanced HNSCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed initially resectable locally advanced head and neck squamous cell carcinoma planned for surgery
- HPV status confirmed by P16 immunostaining
- Male or female aged 18 to 70 years
- Able to provide informed consent and comply with study requirements
- Eastern Cooperative Oncology Group performance status less than 2
- Adequate bone marrow, liver, kidney, heart, lung, and other organ functions to tolerate treatment
- Willing and able to attend visits, treatments, laboratory tests, and other study procedures
You will not qualify if you...
- Any clinical illness such as bleeding, active infection, or mental illness that would prevent safe participation
- Unable to accept radiotherapy as part of standard treatment
- Requirement for long-term oral steroids (20 mg prednisone equivalent or more per day), except inhaled, local, or non-absorbable steroids
- Autoimmune diseases including inflammatory bowel disease, rheumatoid arthritis, autoimmune hepatitis, systemic sclerosis, systemic lupus erythematosus, autoimmune vasculitis, or autoimmune neuropathy like Guillain Barre syndrome
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Actively Recruiting
Research Team
F
Feng Jiang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here