To evaluate the efficacy of SHR-8068 combined with Adebrelimab and Bevacizumab compared with Sintilimab combined with Bevacizumab for the first-line treatment of advanced HCC
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
590
SHR-8068: injection, 50 mg/10 mL, intravenous infusion
Adebrelimab: injection, 600 mg/12 mL, intravenous infusion
Bevacizumab: injection, 100 mg/4 mL, intravenous infusion
Anhui Provincial Hospital
Hefei, Anhui, China
RECRUITINGProgression Free Survival (PFS)
Time frame: From Randomization to the first occurrence of disease progression as determined by the Blinded Independ Review Committee (BIRC) according to RECIST v1.1 or initiation of new anti-tumor therapy (up to approximately 36 months)
Overall survival (OS)
OS is defined as the time from randomization to death from any cause
Time frame: From randomization to death from any cause (whichever occurs first) (up to approximately 36 months)
Time to Progression (TTP)
TTP is defined as the time from randomization to the until first evidence of disease progression as determined by the Blinded Independ Review Committee (BIRC) according to RECIST v1.1
Time frame: From randomization to the first occurrence of disease progression as determined by the Blinded Independ Review Committee (BIRC) according to RECIST v1.1 (up to approximately 36 months)]
Disease Control Rate (DCR)
DCR is defined as the proportion of participants with Complete Response (CR), Partial Response (PR) or Stable Disease (SD), as determined by the Blinded Independ Review Committee (BIRC) according to RECIST v1.1
Time frame: From Randomization to the first occurrence of disease progression as determined by the Blinded Independ Review Committee (BIRC) according to RECIST v1.1 or initiation of new anti-tumor therapy (up to approximately 36 months)
Objective Response Rate (ORR)
ORR is defined as the proportion of participants with Complete Response (CR) or Partial Response (PR), as determined by the Blinded Independ Review Committee (BIRC) according to RECIST v1.1
Time frame: From Randomization to the first occurrence of disease progression or initiation of new anti-tumor therapy (up to approximately 36 months)
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Sintilimab: injection, 100 mg/10 mL, intravenous infusion
Duration of Response (DoR)
DOR is defined as the time from the first occurrence of a confirmed objective response to disease progression as determined by the Blinded Independ Review Committee (BIRC) according to RECIST v1.1 or death from any cause (whichever occurs first)
Time frame: From the first occurrence of a confirmed objective response to disease progression as determined by the Blinded Independ Review Committee (BIRC) according to RECIST v1.1 or death from any cause (whichever occurs first) (up to approximately 36 months)
Time to Response (TTR)
TTR is defined as time from the randomization of Complete Response (CR) or Partial Response (PR) by the Blinded Independ Review Committee (BIRC) according to RECIST v1.1
Time frame: From the first occurrence of complete response (CR) or partial response (PR) as determined by the Blinded Independ Review Committee (BIRC) according to RECIST v1.1 (up to approximately 36 months)
The incidence, severity and relevance to investigational drugs of adverse events (AE) and serious adverse events (SAE) according to NCI-CTCAE v5.0
Time frame: From the ICF date until the end of the safety follow-up or initiation of new anti-tumor therapy (up to approximately 36 months)