This is a multicenter, Phase 3 clinical trial to evaluate the efficacy and safety of SHR-8068, Adebrelimab, and Bevacizumab and TACE versus Placebo with TACE in incurable hepatocellular carcinoma. Participants will continue treatment until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
690
SHR-8068+ Adebrelimab+ Bevacizumab,intravenous infusion,Transarterial Chemoembolization(TACE)
SHR-8068 Placebo+ Adebrelimab Placebo+ Bevacizumab Placebo,intravenous infusion,Transarterial Chemoembolization(TACE)
SHR-8068 Placebo +Adebrelimab+ Bevacizumab,intravenous infusion,Transarterial Chemoembolization(TACE)
Zhongshan Hospital,Fudan University
Shanghai, Shanghai Municipality, China
Progression-free survival (PFS) assessed by investigator
Time frame: Until progression, assessed up to approximately 2 years
Progression-free survival (PFS) assessed by Blinded Independ Review Committee( BIRC)
Time frame: Until progression, assessed up to approximately 2 years
Overall survival (OS)
Time frame: Until study completion, assessed up to approximately 2 years
Objective response rate (ORR)
Time frame: Until study completion,assessed up to approximately 2 years
Disease control rate (DCR)
Time frame: Until study completion,assessed up to approximately 2 years
Duration of objective tumor response (DoR)
Time frame: Until study completion,assessed up to approximately 2 years
Adverse events (AEs)
Time frame: Until study completion,assessed up to approximately 2years
Serious adverse events (SAEs)
Time frame: Until study completion,assessed up to approximately 3 years
Pharmacokinetics parameters of SHR-8068 、Adebrelimab:serum concentration
Time frame: Approximately 90 days post-last dose
Immunogenicity indicators of SHR-8068 、Adebrelimab: drug resistant antibody (ADA) and neutralizing antibody (NAb)
Time frame: Approximately 90 days post-last dose
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