To evaluate the tolerability and safety of SHR-8068 in combination with Adebrelimab and Bevacizumab in subjects with advanced HCC; To evaluate the efficacy of SHR-8068 in combination with Adebrelimab and Bevacizumab in subjects with advanced HCC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
129
intravenous infusion
intravenous infusion
intravenous infusion
Anhui Provincial Hospital Ethics Commitee
Hefei, Anhui, China
RECRUITINGDose Limiting Toxicity
Time frame: The observation period is 21 days after the first dose
Incidence and severity of grade ≥3 drug-related adverse events and serious adverse events of the two-drug or three-drug combination
Time frame: The observation period is from the time when all informed subjects signed the informed consent to the end of the safety follow-up period, up to 2 years
Objective Response Rate
determined using RECIST v1.1 criteria, defined as best overall response (complete or partial response) across all assessment time points
Time frame: At the time point of every 6 or 9 weeks, up to 2 years
Disease Control Rate, determined using RECIST v1.1 criteria
Time frame: At the time point of every 6 or 9 weeks, up to 2 years
Progression-Free-Survival assessed by investigator
Time frame: up to 2 years]
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