An open-label multi-center phase II study to evaluate the efficacy and safety of anti-PD-1/CTLA-4 bispecific antibody AK104 alone or in combination with lenvatinib in patients with advanced hepatocellular carcinoma.
This is a multi-center, multi-cohort, open-label phase 2 clinical study to evaluate the anti-tumor activity, safety, PK profile, immunogenicity and potential biomarkers of AK104 alone or in combination with for the treatment of advanced hepatocellular carcinoma
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Subjects will receive AK104 and lenvatinib until disease progression or for a maximum of 24 months
Subjects will receive AK104 until disease progression or for a maximum of 24 months
The first affilited hospital zhejiang university school of medcine
Hangzhou, Zhejiang, China
Objective response rate (ORR)
ORR is defined as the proportion of subjects with confirmed CR or PR, based on RECIST v1.1.
Time frame: Up to 2 years
Disease control rate (DCR)
The DCR is defined as the proportion of subjects with CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for ≥8 weeks) based on RECIST Version 1.1.
Time frame: Up to 2 years
Duration of response (DoR)
Duration of response is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first
Time frame: Up to 2 years
Progression-free survival (PFS)
Progression-free survival is defined as the time from the start of treatment with AK104 until the first documentation of disease progression or death due to any cause, whichever occurs first
Time frame: Up to 2 years
Number of participants with adverse events (AEs)
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment
Time frame: the time of informed consent signed through 90 days after the last dose of AK104 and Lenvatinib
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