Toripalimab Maintenance for Locally Advanced Head and Neck Squamous Cell Carcinoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorNanfang Hospital, Southern Medical University
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Toripalimab
DrugWithin 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.
Treatment groups
28 Participants
are divided into 1 treatment groupGroup A: ToripalimabExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
2-year progression-free survival
The time from the day of first-line systemic treatment to disease progression or death.
Time frame
2 yearsSecondary outcomes
1
2-year Overall Survival
The time from the day of first-line treatment to the death of any cause.
Time frame
2 yearsOther outcomes
1
≥Grade 3 Treatment-Related Adverse Events
Any adverse signs ( including abnormal laboratory results ), symptoms or diseases that are time-related to the use of the study drug, regardless of whether there is a causal relationship with the study drug
Time frame
2 yearsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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