To evaluate the efficacy and safety of cadonilimab combined with AK112 as second-line therapy in patients with advanced hepatocellular carcinoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Cadonilimab (AK104): 10mg/kg or 15mg/kg Q6W iv D8 (dose choosing depends on the outcome of the dose climb stage) AK112: 20mg/kg Q3W iv D1 Eligible patients will receive AK104 plus AK112 until disease progression or withdrawn ICF or death, whichever comes first.
Harbin Medical University Hospital
Harbin, China
Progression-Free-Survival
Defined as the time between signing the informed consent form to the disease progression (according to RECIST v1.1 criteria) or death due to any cause.
Time frame: From the first drug administration up to two years
Objective Response Rate
Defined as the proportion of patients who achieved complete response (CR) and partial response (PR) according to RECIST v1.1.
Time frame: From the first drug administration up to two years
Disease control Rate
Defined as the proportion of patients who achieved complete response (CR), partial response (PR), and stable disease (SD) according to RECIST v1.1.
Time frame: From the first drug administration up to two years
Overall survival
Defined as the time between the first dose to death due to any causes.
Time frame: From the first drug administration up to two years
Incidence of Adverse Events
Use NCI-CTCAE version 5.0 for classification and grading.
Time frame: From the first drug administration to within 90 days for the last dose
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