This is an open-label, multi-center, single-arm, phase II study to evaluate the efficacy and safety of lenvatinib in combination with cadonilimab as second-line therapy in subjects with advanced hepatocellular carcinoma (HCC) who failed first-line standard therapy of immunotheray and antiangiogenic therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Cadonilimab (AK104): 15mg/kg Q3W iv D1 + Lenvatinib: 8 mg (body weight \<60 kg) or 12mg (body weight ≥60 kg) orally QD. Eligible patients will receive AK104 plus Lenvatinib until disease progression or withdrawn ICF or death, whichever comes first.
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Sun Yat-sen University Cancer Center)
Guangzhou, China
Eastern Hepatobiliary Surgery Hospital
Shanghai, China
Objective Response Rate (ORR) per RECIST v1.1
Defined as the proportion of patients who achieved complete response (CR) and partial response (PR) according to RECIST v1.1.
Time frame: Up to two years
Objective Response Rate (ORR) per mRECIST
Defined as the proportion of patients who achieved complete response (CR) and partial response (PR) according to mRECIST.
Time frame: Up to two years
Disease control Rate (DCR)
Defined as the proportion of patients who achieved complete response (CR), partial response (PR), and stable disease (SD) according to RECIST v1.1 and mRECIST respectively.
Time frame: Up to two 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
Progression-Free-Survival (PFS)
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: Up to two years
Overall survival Overall survival (OS)
Defined as the time between the first dose to death due to any causes.
Time frame: Up to three years
Incidence of Adverse Events
Adverse events (AEs) ; serious adverse events (SAEs); Treatment related Adverse events (TRAEs); Use NCI-CTCAE version 5.0 for classification and grading.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Up to two years