It is an exploratory clinical study aimed to evaluate the efficacy and safety of TACE combined with Camrelizumab in the treatment of patients with BCLC stage B and C HCC.Treatment will continue until disease progression or intolerable toxicity or patients withdrawal of consent,and the target sample size is 60 individuals.
This is a prospective, single-center and single-arm exploratory clinical study designed to evaluate the efficacy and safety of TACE combined with Camrelizumab in the treatment of patients with BCLC stage B and C hepatocellular carcinoma.Treatment will continue until disease progression or intolerable toxicity or patients withdrawal of consent,and the target sample size is 60 individuals.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Camrelizumab(200mg q3w ivgtt) combined with TACE
Camrelizumab(200mg q3w ivgtt) combined with TACE
Department of Interventional Radiology, Zhongshan Hospital, Fudan University.
Shanghai, Shanghai Municipality, China
Progression Free Survival
the time from enrollment to the first disease progression or death from any cause
Time frame: an expected average of 8 months
Time to progression
the time from enrollment to the first disease progression
Time frame: An expected average of 8 months
Overall survival
the time from enrollment to the death from any cause
Time frame: An expected average of 24 months
Objective response rate
evaluated by investigators with mRECIST
Time frame: An expected average of 8 months
Disease control rate
evaluated by investigators with mRECIST
Time frame: An expected average of 8 months
Duration of response
evaluated by investigators with mRECIST
Time frame: An expected average of 8 months
The incidence of AEs and SAEs by NCI-CTCAE v5.0
Safety index
Time frame: An expected average of 8 months
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