There're 2 parts in this interventional study: 1. The goal of phase Ib trial is to evaluate the safety and tolerability of AK112 in combination therapies for the purpose of observing the incidence of dose limit toxicity (DLT) as well as the confirmation of maximum tolerable dose (MTD) in the treatment of advanced hepatocellular carcinoma (HCC), so as to determine the recommended phase 2 dose (RP2D) in the second part of the trial. 2. The goal of phase II trial is to evaluate the safety and efficacy of AK112 in combination therapy or monotherapy in the treatment of HCC compared to the combination of Sintilimab and Bevacizumab biosimilar.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
280
Following a predefined dose and date.
Following a predefined dose and date.
Following a predefined dose and date.
Following a predefined dose and date.
Following the local label direction.
Following the local label direction.
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGCancer Hospital of Shandong First Medical University (Shandong Cancer Institute,Shandong Cancer Hospital)
Jinan, Shandong, China
RECRUITINGNumber of subjects with dose limiting toxicities (DLTs)
DLTs will be assessed during the first three weeks of treatment. DLTs are defined as toxicities that meet pre-defined severity criteria, and assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the DLT observation period.
Time frame: During the first three weeks.
Number of subjects with adverse events (AEs)
AE refers to any untoward medical occurrence or deterioration of existing medical event after the subject signed the ICF, whether or not considered related to the study treatment.
Time frame: From the time of informed consent signed through 90 days after the last dose of study drug.
Objective Response Rate (ORR) (Phase II)
ORR is defined as the proportion of subjects with BOR response of CR or PR (based on RECIST Version 1.1).
Time frame: Up to approximately 2 years.
Objective Response Rate (ORR) (Phase Ib)
ORR is defined as the proportion of subjects with BOR response of CR or PR (based on RECIST Version 1.1).
Time frame: Up to approximately 2 years.
Objective Response Rate (ORR) Per mRECIST
ORR is defined as the proportion of subjects with BOR response of CR or PR (based on mRECIST).
Time frame: Up to approximately 2 years.
Disease control rate (DCR)
DCR is defined as the proportion of subjects with response of CR, PR and SD (based on RECIST Version 1.1).
Time frame: Up to approximately 2 years.
Duration of Response (DoR)
The time from first documented evidence of CR or PR until time of first documented disease progression.
Time frame: Up to approximately 2 years.
Progression Free Survival (PFS)
PFS is defined as the interval between first dose and the earliest date of disease progression or death due to any cause.
Time frame: Up to approximately 2 years.
Time to response (TTR)
Time between date of start of treatment until first documented response (CR or PR).
Time frame: Up to approximately 2 years
Overall survival (OS)
OS is defined as the time from first dose until death due to any cause
Time frame: From baseline until death due to any cause.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.