To evaluate the efficacy and safety of cadonilimab combined with Regorafenib in patients with hepatocellular carcinoma who failed camrelizumab plus apatinib.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
cadonilimab: 6mg/kg iv D1 Q2W; regorafenib: 80mg QD oral; Eligible patients will receive cadonilimab combined with regorafenib, until disease progression or intolerable toxicity or death or withdrawal of informed consent, whichever occurred first
Mengchao Hepatobiliary Hospital, Fujian Medical University
Fuzhou, Fujian, China
RECRUITINGobjective response rate (ORR) per RECIST1.1
The proportion of all subjects with the best overall response (BOR) as complete remission (CR) or partial remission (PR) according to RECIST 1.1 criteria.
Time frame: Up to two years
Progression-free survival(PFS)
PFS was defined as the time from the first dose to the time of the first documented tumor progression (assessed by RECIST1.1 criteria) or the time of death from any cause, whichever occurred first.
Time frame: Up to two years
Overall survival(OS)
Defined as the time from the first dose to the death from any cause.
Time frame: Up to three years
Duration of response (DOR)
Defined as the time from the first dose to disease progression or death in patients who achieve complete or partial response
Time frame: Up to two years
Occurence of AE and SAE
Occurence of Adverse Event (AE) and Serious Adverse Event (SAE) (NCI CTCAE 5.0)
Time frame: Up to two years
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