This is an open label, multi-center, randomized, controlled phase III study, to evaluate the efficacy and safety of sintilimab plus bevacizumab as adjuvant therapy in hepatocellular carcinoma (HCC) patients who are at high risk of recurrence after radical resection
There is no stardard adjuvant treatment for HCC. This study is to to evaluate the efficacy and safety of sintilimab plus bevacizumab as adjuvant therapy in HCC patients who are at high risk of recurrence after radical resection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
246
Sintilimab 200mg IV Q3W
Bevacizumab 7.5mg/kg IV Q3W
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Recurrence-free Survival (RFS)
RFS is defined as the time from randomization to the first documented occurrence of local, regional, or metastatic HCC as determined by the investigator, or death due to any cause (whichever occurs first).
Time frame: up to 36 months after randomization
Overall Survival (OS)
OS is defined as the time from the date of randomisation until death due to any cause
Time frame: up to 48 months after randomization
RFS Rate at 12 and 24 months
RFS rate defined as the proportion of patients without recurrence or death from any cause at 12 and 24 months after randomization.
Time frame: at 12 and 24 months after randomization
OS Rate at 24 and 36 Months
OS rate defined as the proportion of patients who have not experienced death from any cause at 24 and 36 months after randomization.
Time frame: at 24 and 36 months after randomization
TTR(time to recurrence)
TTR is defined as the time the date of randomisation until first documented disease recurrence.
Time frame: up to 36 months after randomization
Adverse Events (AEs)
The grade of AEs and the number of patients with AEs are assessed by the investigator based on CTCAE v5.0 from the date of randomization to 90 days after last dose of study treatment.
Time frame: up to 48 months after randomization
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