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Trial Title:
Neoadjuvant SBRT in Localized Advanced HNSCC
NCT ID:
NCT06306846
Condition:
Head and Neck Squamous Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Cetuximab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
SBRT+immunochemotherpy
Description:
SBRT radiotherapy,followed with PD-1 monoclonal antibody and TP chemotherapy
Arm group label:
experimental
Other name:
immunochemotherapy
Intervention type:
Drug
Intervention name:
Immunochemotherapy
Description:
PD-1 monoclonal antibody and TP chemotheapy
Arm group label:
control
Intervention type:
Drug
Intervention name:
cetuximab+immunochemotharpy
Description:
PD-1 monoclonal antibody and TP chemotheapy combined with cetuximab
Arm group label:
Cetuximab+immunochemo
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
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Zhejiang Cancer Hospital
Address:
City:
Hangzhou
Zip:
310022
Country:
China
Status:
Recruiting
Contact:
Last name:
Feng Jiang, MD
Phone:
0086-571-88128202
Email:
jiangfeng@zjcc.org.cn
Start date:
October 1, 2023
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Jiang Feng
Agency class:
Other
Source:
Zhejiang Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06306846