This ia a single-arm, not-randomized, open-label phase II study. The purpose of this study is to evaluate the safety and efficacy of KN046 (PD-L1 /CTLA-4 Bispecific antibody) combined with Lenvatinib(TKI) for the treatment of advanced hepatocellular carcinoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
55
Subjects enrolled in the study will be intravenously administered KN046 5mg/kg every 3 weeks (Q3W), until disease progression, or unacceptable toxicity, or withdrawal of consent, or lost to follow-up, or died, or treatment for 2 years, or the investigator decides to terminate.
Subjects enrolled in the study will receive lenvatinib 12 mg (BW≥60 kg) or 8 mg (BW\<60 kg) orally once a day (QD) ,until disease progression, or unacceptable toxicity, or withdrawal of consent, or lost to follow-up, or died, or treatment for 2 years, or the investigator decides to terminate.
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
ORR
objective response rate (ORR) based on the RECIST 1.1 by investigator
Time frame: 1 year after the last patient's enrollment
ORR
objective response rate (ORR) based on the mRECIST 1.1 and imRECIST respectively by investigator
Time frame: 1 year after the last patient's enrollment
DCR
disease control rate (DCR) based on the RECIST 1.1,mRECIST 1.1 and imRECIST respectively by investigator
Time frame: 1 year after the last patient's enrollment
DOR
duration of response (DOR) based on the RECIST 1.1,mRECIST 1.1 and imRECIST respectively by investigator
Time frame: 1 year after the last patient's enrollment
TTR
time to response (TTR) based on the RECIST 1.1,mRECIST 1.1 and imRECIST respectively by investigator
Time frame: 1 year after the last patient's enrollment
PFS
Time frame: 1 year after the last patient's enrollment
OS-12m rate
12-month overall survival rate
Time frame: 1 year after the last patient's enrollment
OS
overall survival
Time frame: 2 year after the last patient's enrollment
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