The purpose of the study is to assess the safety, tolerability and effectiveness of Sintilimab in combination with IBI305 in patients with HCC as the first-line treatment compared with Sorafenib. This study is a randomised, Open-label,Multi-center Study. The primary endpoint is overall survival.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
595
Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Overall survival (OS)
Time frame: up to 24 months after randomization
Progression-free survival (PFS)
Progression-free survival (PFS) in two arms based on RECIST V1.1 by Independent Radiological Review Committee, IRRC.
Time frame: up to 24 months after randomization
PFS
PFS in two arms based on RECIST V1.1 by investigator.
Time frame: up to 24 months after randomization
Objective response rate (ORR)
Objective response rate (ORR) in two arms based on RECIST V1.1 by IRRC and investigator .
Time frame: up to 24 months after randomization
Disease control rate (DCR)
DCR in two arms based on RECIST V1.1 by IRRC and investigator.
Time frame: up to 24 months after randomization
Duration of response (DOR)
DOR in two arms based on RECIST V1.1 by IRRC and investigator.
Time frame: up to 24 months after randomization
Time to progression (TTP)
TTP in two arms based on RECIST V1.1 by IRRC and investigator.
Time frame: One assessment was performed every 6 weeks (±7 days) from the time of randomization, and once every 12 weeks (±7 days) after 48 weeks.
Time to response (TTR)
TTR in two arms based on RECIST V1.1 by IRRC and investigator.
Time frame: up to 24 months after randomization
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PFS
PFS in two arms based on mRECIST by IRRC.
Time frame: up to 24 months after randomization
Objective response rate (ORR)
Objective response rate (ORR) in two arms based on mRECIST by IRRC.
Time frame: up to 24 months after randomization
Time to progression (TTP)
TTP in two arms based on mRECIST by IRRC.
Time frame: up to 24 months after randomization
Duration of response (DOR)
DOR in two arms based on mRECIST by IRRC.
Time frame: up to 24 months after randomization
Disease control rate (DCR)
DCR in two arms based on mRECIST by IRRC.
Time frame: up to 24 months after randomization
Time to response (TTR)
TTR in two arms based on mRECIST by IRRC.
Time frame: up to 24 months after randomization
Anti-drug antibody (ADA)
Immunogenicity measured by anti-drug antibody (ADA) for Sintilimab and IBI305.
Time frame: up to 24 months after randomization
EORTC QLQ-C30
Time frame: up to 24 months after randomization
EORTC QLQ-HCC18
Time frame: up to 24 months after randomization