About this trial
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.
Eligibility criteria
Qualifiers
Locally advanced squamous cell carcinoma of the head and neck (AJCC8thIII-IV) confirmed by pathology in the initial treatment;
No residual lesions after first-line surgery/radiotherapy/chemotherapy/targeted comprehensive treatment;
Associated high risk factors: T3-4, regional lymph node positive, vascular invasion, neural invasion, lymph node capsular invasion, incisional margin positive;
The patients' age is between 18 and 70 years old;
Disqualifiers
Distant metastasis of the tumor was detected upon enrollment;
Have a history of allergy to PD-1 monoclonal antibody or drug components;
There has been a history of other malignant tumors within the past 5 years or at the same time, except for cured skin basal cell carcinoma, cervical carcinoma in situ, and thyroid papillary carcinoma;
Uncontrolled clinical cardiac symptoms or diseases, such as: (1) heart failure above NYHA class II; (2) unstable angina; (3) myocardial infarction within 1 year; (4) patients with clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention;
Trial design
Treatments tested in this trial
- Toripalimab
Treatment groups
Locations
Sponsors and collaborators
Nanfang Hospital, Southern Medical University
Lead sponsor