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NCT Number: NCT06306846

Neoadjuvant SBRT in Localized Advanced HNSCC

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.

Recruiting

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Any clinical illness, such as hemorrhage, active infection, or mental illness, that can hinder safe participation or adherence of research procedures.
  • 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.
  • 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.

Treatment and study plan

SBRT+immunochemotherpy

Radiation

SBRT radiotherapy,followed with PD-1 monoclonal antibody and TP chemotherapy

Other names: immunochemotherapy

Immunochemotherapy

Drug

PD-1 monoclonal antibody and TP chemotheapy

cetuximab+immunochemotharpy

Drug

PD-1 monoclonal antibody and TP chemotheapy combined with cetuximab

Primary outcomes

  1. major pathology response (MPR)

    Time frame: 4-6 weeks after the end of the neoadjuvant therapy

    major pathology response

Study contacts

Contact information is provided by the study sponsor or research team.

Feng Jiang, MD

CONTACT

[email protected]

0086-571-88128202

Sponsors and collaborators

Lead sponsor

Jiang Feng

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 12, 2024
Registry last updated
Mar 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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