This is a non-randomized, phase II, open-label study. The goal of this clinical research study is to investigate how well sintilimab works in preventing high-risk oral premalignant lesions cancerization.
this study is a non-randomized, phase II, open-label study. Phase II clinical trials test the safety and effectiveness of an investigational drug or combination of drugs to learn whether it works in preventing or treating a disease. the purpose of this study is to evaluate the effectiveness of sintilimab in preventing the onset of oral cancer in patients with high-risk oral premalignant lesions, who had oral cancer at least once before.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
29
Sintilimab is a type of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack cancer cells. other name: IBI308
Shanghai ninth people's hospital
Shanghai, Shanghai Municipality, China
oral cancer incidence rate
The proportion of patients who has been diagnosed with oral cavity cancer
Time frame: 2 years
clinical response rate of oral premalignant lesions
The proportion of patients whose oral premalignant lesions experienced a Complete Response or a Partial Response
Time frame: 2 years
pathologically response rate of oral premalignant lesions
The proportion of patients whose oral premalignant lesions experienced a locally complete response or decrease of histopathological grade
Time frame: 2 years
Duration of Response (DoR) of oral premalignant lesions
the time from the date for first documented response of complete response (CR) or partial response (PR) until the date for the first documented response of progressive disease (PD), incidence of oral cancer or death in the absence of progression.
Time frame: 2 years
2 year oral-cancer-free survival
time from randomization to the development of histologically confirmed oral cancer or death of any cause, whichever occurs first
Time frame: 2 years
Treatment-related Adverse Events (AEs)
The grade of AEs and the number of patients with AEs are assessed by the investigator based on CTCAE v4.0 from the date of randomization to 90 days after last dose of study treatment
Time frame: From the date of randomization to 90 days after last dose of study treatment
Overall survival (OS)
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OS (per RECIST 1.1 as assessed by the investigator) is defined as the time from the date of randomisation until death due to any cause.
Time frame: 2 year
quality of life(QOL)
EORTC QLQ-C30 questionnaires
Time frame: 2 years