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Neoadjuvant SBRT in Localized Advanced HNSCC

NCT06306846 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2024-03-12

No results posted yet for this study

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.

Conditions

  • Head and Neck Squamous Carcinoma

Interventions

RADIATION

SBRT+immunochemotherpy

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

DRUG

Immunochemotherapy

PD-1 monoclonal antibody and TP chemotheapy

DRUG

cetuximab+immunochemotharpy

PD-1 monoclonal antibody and TP chemotheapy combined with cetuximab

Sponsors & Collaborators

  • Jiang Feng

    lead OTHER

Principal Investigators

  • feng Jiang, MD · Zhejiang Cancer Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-01
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06306846 on ClinicalTrials.gov