The purpose of this phase Ib/II multicenter randomized control study is to investigate the efficacy and safety of peri-operative treatment with combination of CTLA-4, PD-1 antibodies and bevacizumab in resectable HCC
This study is a prospective, national multi-center clinical trial. Patients with initially resectable hepatocellular carcinoma were randomly assigned to receive neoadjuvant therapy in three groups: IBI310+ sintilimab + bevacizumab (Group A), IBI310+ sintilimab (Group B), and Sintilimab + bevacizumab (Group C).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
systemic therapy
systemic therapy
systemic therapy
Average depth of pathological response
Pathological response depth is defined as the proportion of non-viable tumors in surgical specimens to the total sample after neoadjuvant therapy. The average pathological response depth is defined as the average value of the pathological response depth.
Time frame: 6 months
1y-RFS rate
The proportion of patients without disease recurrence or death within 1 year following the second randomization
Time frame: 12 months
1y-EFS rate
The proportion of patients without disease progression precluding surgical resection, post-operative disease recurrence, or death within 1 year after the first randomization
Time frame: 12 months
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