A study to evaluate efficacy and safety of transarterial chemoembolization (TACE) in combination with Camrelizumab and Rivoceranib (Apatinib) therapy in patients with incurable hepatocellular carcinoma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
423
TACE. Camrelizumab,200mg,iv,once every 3 weeks. Apatinib mesylate, 250 mg, administered orally once daily,once every 3 weeks.
TACE Alone.
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
PFS assessed by BIRC
PFS is defined as the time from the date of randomization until the date of first objective disease progression or death (whichever occurs first).
Time frame: approximately 5 years
OS
OS is defined as the time from the date of randomization until death due to any cause.
Time frame: approximately 5 years
ORR
ORR is defined as the percentage of participants in the analysis population who have a CR or PR.
Time frame: approximately 5 years
DCR
DCR is defined as the percentage of participants in the analysis population who have a CR, PR or SD.
Time frame: approximately 5 years
DoR
DOR is defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.
Time frame: approximately 5 years
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v5.0
Time frame: approximately 5 years
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