This study aims to evaluate the efficacy and safety of concurrent chemoradiotherapy based of cisplatin with sintilimab as first-line therapy for patients with advanced oral cavity squamous cell carcinoma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Concurrent Chemoradiotherapy Based of Cisplatin Plus Sintilimab.
Concurrent Chemoradiotherapy Based of Cisplatin
Department of Medical Oncology, Central Hospital of Yichang City, the First Clinical Medical College of Three Gorges University
Yichang, Hubei, China
RECRUITINGCompare Progression Free Survival (PFS) between Chemoradiotherapy Based of Cisplatin + Sintilimab Regimen and Chemoradiotherapy Based of Cisplatin Regimen using RECIST 1.1.
PFS was defined as the time between the date of randomization and the date of first documented disease progression or death, whichever occurs first. Disease progression was determined based on investigator assessment using response evaluation criteria In solid tumors (RECIST) v1.1.
Time frame: approximately 24 months
Compare objective response rate(ORR) between Chemoradiotherapy Based of Cisplatin + Sintilimab Regimen and Chemoradiotherapy Based of Cisplatin Regimen using RECIST 1.1.
ORR was defined as the percentage of participants with confirmed objective tumor response, complete response (CR) or partial response (PR), as determined by investigator using RECIST v1.1 criteria.
Time frame: approximately 24 months
Compare Overall Survival (OS) between Chemoradiotherapy Based of Cisplatin + Sintilimab Regimen and Chemoradiotherapy Based of Cisplatin Regimen.
Overall Survival (OS) was defined as the time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as dead at the time of analysis was censored at the date when they were last known to be alive.
Time frame: approximately 24 months
Compare Disease Control Rate (DCR) between Chemoradiotherapy Based of Cisplatin + Sintilimab Regimen and Chemoradiotherapy Based of Cisplatin Regimen using RECIST 1.1.
DCR was defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD).
Time frame: approximately 24 months
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