To evaluate the efficacy and safety of AK104 plus lenvatinib combined with on-demand TACE in participants with unresectable, non-metastatic hepatocellular carcinoma
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Subjects will receive AK104 until disease progression or for a maximum of 24 months
Subjects will receive lenvatinib until disease progression or for a maximum of 24 months
On demand TACE
The First Hospital of Beijing University
Beijing, Beijing Municipality, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Hunan Cancer Hospital
Changsha, Hunan, China
Progression-free survival (PFS)
Progression-free survival is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, which ever occurs first.
Time frame: Up to 2 years
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
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
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Shandong Cancer Hospital
Jinan, Shandong, China