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Toripalimab Maintenance for Locally Advanced Head and Neck Squamous Cell Carcinoma

NCT05773079 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2024-04-01

No results posted yet for this study

Summary

The guidelines for locally advanced head and neck squamous cell carcinoma currently recommend surgery / radiotherapy / chemotherapy / targeted therapy. However, the median PFS of patients with high risk factors after comprehensive treatment was about 17 months, and the 2-year PFS rate was about 40 %. The KEYNOTE-048 study showed that PD-1 monoclonal antibody alone or in combination with chemotherapy significantly improved survival and was safe for recurrent / metastatic head and neck squamous cell carcinoma. Therefore, PD-1 monoclonal antibody has become the first-line treatment of metastatic head and neck squamous cell carcinoma. For locally advanced head and neck squamous cell carcinoma, the existing studies on immunotherapy for neoadjuvant or concurrent chemoradiotherapy have not been clearly concluded. We previously used PD-1 monoclonal antibody for the maintenance treatment of patients after the first-line treatment of locally advanced head and neck squamous cell carcinoma, without residual tumor, which showed a trend of prolonged survival. Therefore, this study intends to explore whether the maintenance treatment of PD-1 monoclonal antibody terripril can further improve the survival of patients with locally advanced head and neck squamous cell carcinoma with high risk factors and no residual tumor after first-line comprehensive treatment, and the safety is good.

Conditions

  • Locally Advanced Head and Neck Squamous Cell Carcinoma

Interventions

DRUG

Toripalimab

Within 4 to 12 weeks after the first line of treatment, the maintenance treatment of Toripalimab was started, and 240 mg of Toripalimab was injected intravenously every 3 weeks (the maintenance treatment time was not more than 1 year, until there was an intolerable toxic reaction, or disease progression, or withdrawal of consent, or the investigator judged that it was necessary to withdraw from the treatment, or the subject had received treprizumab treatment for a cumulative period of 1 year or other reasons specified in the protocol). During the treatment period, tumor imaging evaluation shall be conducted every 3 months to see the research process description for details, and the evaluation shall be conducted according to the evaluation criteria of recist. If the evaluation is progress, the treatment shall be stopped.

Sponsors & Collaborators

  • Nanfang Hospital, Southern Medical University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2024-05-31
Primary Completion
2026-02-28
Completion
2028-06-30

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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 NCT05773079 on ClinicalTrials.gov