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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

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