This study is a phase II, open label, single-arm and exploratory clinical trial. The purpose of this study is to observe the efficacy and safety of consolidation immunotherapy with Toripalimab following postoperative radiotherapy or chemoradiotherapy for patients with locally advanced head and neck squamous cell carcinomas (HNSCC).
Postoperative with adverse prognostic factors in patients with locally advanced head and neck squamous cell carcinoma.
Have received postoperative adjuvant radiotherapy (chemo) therapy, and the end of the treatment is not more than 2 months.
Greater than or equal to 18 and less than 70 years of age at time of study entry.
ECOG performance status of 0 or 1.
Is currently participating in or has participated in a study of an investigational agent within 4 weeks of the first dose of treatment or has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
Has had another known invasive malignancy within the previous 5 years （With the exception of basal cell carcinoma of the skin, carcinoma in situ of the cervix, and papillary carcinoma of the thyroid, which has been cured）.
If subject received major surgery for any other reason, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
Active, known or suspected autoimmune disease.
Single group
Consolidation Toripalimab
DrugToripalimab consolidation therapy after radiotherapy or chemoradiotherapy, 240mg IV, every 3 weeks, until progressive disease (PD), start new anti-cancer therapy, intolerable toxicity, withdraw informed consent or other conditions that require study treatment discontinuation. Toripalimab will be given at a maximum of 12 months.
2-year Disease-Free Survival Rate
The 2-year DFS rate was defined as the rate of progression or death due to disease recurrence within 2 years.
2-year overall survival rate
Number of patients with evidenced death / number of total patients.
Media Disease-free Survival (mDFS)
The time at which disease progression or death due to disease progression occurred in 50% of patients.
Overall survival
Overall survival will be defined as the time from day 1 of study treatment until death from any cause.
Adverse events
Percentage of adverse events that are possibly, probably or definitely related to study treatment.
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