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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
41
Toripalimab 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.
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China
RECRUITINGSun Yat-sen Memorial Hospital
Guangzhou, Guangdong, China
NOT_YET_RECRUITING2-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.
Time frame: 2 years
2-year overall survival rate
Number of patients with evidenced death / number of total patients.
Time frame: 2 years
Media Disease-free Survival (mDFS)
The time at which disease progression or death due to disease progression occurred in 50% of patients.
Time frame: Up to 5 years
Overall survival
Overall survival will be defined as the time from day 1 of study treatment until death from any cause.
Time frame: 5 years
Adverse events
Percentage of adverse events that are possibly, probably or definitely related to study treatment.
Time frame: 90 days after the first dose of study treatment
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