The purpose of this study is to compare the efficacy and safety of sitravatinib plus tislelizumab or placebo plus tislelizumab versus placebo. The study will also compare the recurrence-free survival (RFS) in participants with hepatocellular carcinoma (HCC) who are at high risk of recurrence after surgical resection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Recurrence-free survival (RFS) as assessed by the investigator between Arm A and Arm D
RFS is defined as the time from the date of randomization until the date of the first documented occurrence of intrahepatic or extrahepatic hepatocellular carcinoma (HCC) as assessed by the investigator, or death from any cause, whichever occurs first.
Time frame: Up to 2 Years
Recurrence-free survival (RFS) as assessed by the investigator between Arm B and Arm D
defined as the time from the date of randomization until the date of the first documented occurrence of intrahepatic or extrahepatic hepatocellular carcinoma as assessed by the investigator, or death from any cause, whichever occurs first.
Time frame: Up to 2 Years
Arm A and Arm B: Recurrence-free survival (RFS)
defined as the time from the date of randomization until the date of the first documented occurrence of intrahepatic or extrahepatic hepatocellular carcinoma as assessed by the investigator, or death from any cause, whichever occurs first.
Time frame: Up to 2 Years
Arm A and Arm C: Recurrence-free survival (RFS)
defined as the time from the date of randomization until the date of the first documented occurrence of intrahepatic or extrahepatic hepatocellular carcinoma as assessed by the investigator, or death from any cause, whichever occurs first.
Time frame: Up to 2 Years
Arm A and Arm D: overall survival (OS)
defined as the time from the date of randomization until the date of death due to any cause
Time frame: Up to 5 Years
Arm B and Arm D: overall survival (OS)
defined as the time from the date of randomization until the date of death due to any cause
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administered intravenously
Time frame: Up to 5 Years
Arm A and Arm B: overall survival (OS)
defined as the time from the date of randomization until the date of death due to any cause
Time frame: Up to 5 Years
Arm A and Arm C: overall survival (OS)
defined as the time from the date of randomization until the date of death due to any cause
Time frame: Up to 5 Years
Arm A and Arm D: time to extrahepatic spread (EHS) as assessed by the investigator
defined as the time from the date of randomization until the date of the first documented occurrence of extrahepatic HCC
Time frame: Up to 2 Years
Arm B and Arm D: time to extrahepatic spread (EHS) as assessed by the investigator
defined as the time from the date of randomization until the date of the first documented occurrence of extrahepatic HCC
Time frame: Up to 2 Years
Arm A and Arm B: time to extrahepatic spread (EHS) as assessed by the investigator
defined as the time from the date of randomization until the date of the first documented occurrence of extrahepatic HCC
Time frame: Up to 2 Years
Arm A and Arm C: time to extrahepatic spread (EHS) as assessed by the investigator
defined as the time from the date of randomization until the date of the first documented occurrence of extrahepatic HCC
Time frame: Up to 2 Years
Number of participants with adverse events (AEs)
Incidence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version (v) 5.0, vital signs, and clinical laboratory test results in the Safety Analysis Set
Time frame: Up to 5 Years
Participants Reported Outcome as measured at Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and its hepatocellular carcinoma cancer module QLQ-HCC18
Quality of Life change with treatment. Scale scores are calculated by averaging items within scales and transforming average scores linearly. All of the scales range in score from 0 to 100
Time frame: Up to 2 Years