This is a randomized, open-label, multicenter Phase Ib study to evaluate the effectiveness and safety of different doses of IBI310, bevacizumab combined with sintilimab in patients with locally advanced or metastatic HCC who have not previously received systemic therapy, are unsuitable for radical surgical resection or local treatment, or have progressive disease after surgical resection or local treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
IBI310 0.5mg/kg IV d1 Q6W
IBI310 0.3mg/kg IV d1 Q6W
sintilimab 200 mg IV d1 Q3W
Objective response rate (ORR)
efficacy
Time frame: The proportion of patients with complete response or partial response, through study completion, an average of 3 years
Duration of Response(DOR)according to RECIST V1.1 criteria
efficacy
Time frame: From date of randomization until the date of first documented progression, up to 48 months
Duration of Response(DOR)according to mRECIST criteria
efficacy
Time frame: From date of randomization until the date of first documented progression, up to 48 months
Disease Control Rate(DCR) according to RECIST V1.1 criteria
efficacy
Time frame: The percentage of patients whose therapeutic intervention has led to a complete response, partial response, or stable disease, through study completion, an average of 3 years
Disease Control Rate(DCR) according to mRECIST criteria
efficacy
Time frame: The percentage of patients whose therapeutic intervention has led to a complete response, partial response, or stable disease, through study completion, an average of 3 years
Time to Progression(TTP)according to RECIST V1.1 criteria
efficacy
Time frame: From date of randomization until the date of first documented progression, up to 48 months
Time to Progression(TTP)according to mRECIST criteria
efficacy
Time frame: From date of randomization until the date of first documented progression, up to 48 months
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bevacizumab 15 mg/kg IV d1,Q3W
Progresison Free Surviva(PFS)according to RECIST V1.1 criteria
efficacy
Time frame: From date of randomization until the date of the first documented progression or date of death from any cause, whichever comes first, up to 48 months
Progresison Free Surviva(PFS)according to mRECIST criteria
efficacy
Time frame: From date of randomization until the date of the first documented progression or date of death from any cause, whichever comes first, up to 48 months
Overall survival (OS)
efficacy
Time frame: From date of randomization until death from any cause,through study completion, an average of 3 years
Immune Best Overall Response(iBOR)according to iRECIST criteria
efficacy
Time frame: The best timepoint response recorded from the start of the study treatment until the end of treatment, taking into account any requirement for confirmation, through study completion, an average of 3 years