To explore the efficacy and safety of candonilimab plus bevacizumab for patients with advanced hepatocellular carcinoma who progressed on atezolizumab plus bevacizumab.
Atezolizumab plus bevacizumab is the first-line treatent for patients with advanced hepatocellular carcinoma. However, the second-line treatment is absent for patients who progressed on atezolizumab plus bevacizumab. Candonilimab is a humanized bisspecific monoclonal antibody against PD-1/ CTLA-4 IgG1. Candonilimab plus lenvatinib showed strong anti-tumor effect, with objective response of 44%. This single-arm, prospective, phase 2 trial is to explore the efficacy and safety of candonilimab plus bevacizumab for patients with advanced hepatocellular carcinoma who progressed on atezolizumab plus bevacizumab.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
10mg/kg, iv.drip, every 3 week
15mg/kg, iv.drip, every 3 week
Cancer Center Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGDCR per RECIST 1.1
DCR (Disease Control Rate) include complete response, partial response and stable Disease per RECIST 1.1
Time frame: 12 months
Overall survival (OS)
OS is the length of time from the date of randomization until death from any cause.
Time frame: 12 months
Progression free survival (PFS)
PFS is defined as the time from the date of randomization to the date of the first objectively documented tumor progression or death due to any cause.
Time frame: 12 months
ORR per RECIST 1.1
Objective response rate (complete response+partial response) per RECIST 1.1
Time frame: 12 months
Adverse events
Safety will be evaluated according to the NCI CTCAE Version 4.03. All observations pertinent to the safety of the study medication will be recorded on the CRF and included in the final report.
Time frame: 30 days
Biomarkers such as PD-L1 expression
The blood specimen and needle biopsy specimen would be collected
Time frame: 12 months
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