The study is being conducted to evaluate the efficacy and safety of SHR-1210 plus FOLFOX4 in subjects with advanced HCC who have never received prior systemic treatment compared to placebo plus FOLFOX4. The primary study hyposis is that Camrelizumab combined with FOLFOX4 treatment can improve Overall Survival when compared with placebo in combination with FOLFOX4 Regimen.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
396
81 Hospital Nanjing
Nanjing, Jiangsu, China
RECRUITINGOverall Survival
OS was defined as the time from randomization to death due to any cause
Time frame: Up to approximately 3 years
Objective Response Rate (ORR) per RECIST 1.1 in all participants
ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1.
Time frame: Up to approximately 6 months
Time to Progression (TTP) per RECIST 1.1 in all participants
Time frame: Up to approximately 3 years
Duration of Response (DoR) per RECIST 1.1 in all participants
Time frame: Up to approximately 3 years
Disease Control Rate (DCR) per RECIST 1.1 in all participants
Time frame: Up to approximately 3 years
Progression-free Survival (PFS) per RECIST 1.1 in all participants
Time frame: Up to approximately 3 years
AE
Time frame: Up to approximately 3 years
Overall Survival (OS) rate at 9 months and 12 months
Time frame: Up to approximately 9 months and 12 months
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