NCT06306846RecruitingPhase 2
Neoadjuvant SBRT in Localized Advanced HNSCC
Neoadjuvant Stereotactic Body Radiotherapy（SBRT）Combined With Immunotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma
Source: ClinicalTrials.gov · Last updated 12 Mar 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 81 (estimated)
- First submitted
- 4 Mar 2024
- Start date
- 1 Oct 2023
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Jiang Feng
- Diseases
- Head and neck cancer
- NCT number
- NCT06306846
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 81
- From 1 Oct 2023 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who cannot accept radiotherapy in standard treatment.
- Long term maintenance of oral steroids (≥ 20mg prednisone equivalent per day) is required, excluding patients with inhaled, local, or non absorbable steroids.
Other illness
- Any clinical illness, such as hemorrhage, active infection, or mental illness, that can hinder safe participation or adherence of research procedures.
- 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.
Who the study is looking for
- Pathologically confirmed initially resectable Localized advanced head and neck squamous cell carcinoma，and plan for surgical resection.
- Immunohistochemical confirmed the HPV status through P16 immunostaining.
- Male or female, Between the aged from 18 to 70 years,
- Able to provide informed consent, comply with agreements, and sign research specific consent documents.
- ZPS is less than 2.
- 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.
- Subjects are willing and able to comply with visits, treatment regimens, laboratory tests, and other requirements of the study as spe.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhejiang Cancer Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.