Hepatocellular Carcinoma
Conditions
Brief summary
A study to evaluate cadonilimab (AK104) + lenvatinib in combination with transarterial chemoembolization (TACE) versus TACE in participants with incurable/non-metastatic hepatocellular carcinoma
Interventions
DRUGAK104
intravenous
DRUGLenvatinib
oral
PROCEDURETACE
TACE (chemo and embolic agent injection into the hepatic artery)
OTHERPlacebo for AK104
intravenous
oral
Sponsors
Akeso
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Has a diagnosis of HCC confirmed by histology/cytology，or meet the clinical diagnostic criteria of the American Association for the Study of Liver Diseases (AASLD) 2. No evidence of metastasis 3. Not amenable to curative surgery or transplantation or curative ablation but amenable to TACE 4. Child Pugh score class A 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment 6. Measurable disease by RECIST 1.1 7. Adequate organ function
Exclusion criteria
1. History of liver transplantation 2. History of hepatic encephalopathy 3. Uncontrolled arterial hypertension 4. Deep venous thrombosis within 3 months before first treatment 5. Bleeding events within the last 6 months 6. Co-infection with HBV and HCV
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Up to approximately 2 years | PFS is defined as the time from randomization to the first documented progressive disease or death due to any cause, whichever occurs first. Responses are according to RECIST 1.1 as assessed by blinded independent central review (BICR). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS per RECIST 1.1 | Up to approximately 2 years | Assessed by investigators |
| Objective Response Rate (ORR) per RECIST 1.1 and Modified Response Evaluation Criteria in Solid Tumors (mRECIST) | Up to approximately 2 years | Assessed by BICR and investigators |
| Overall Survival (OS) | Up to approximately 2 years | OS is defined as the time from randomization to death due to any cause. |
| Disease Control Rate (DCR) per RECIST 1.1 and mRECIST | Up to approximately 2 years | Assessed by BICR and investigators |
| Time to Response (TTR) per RECIST 1.1 and mRECIST | Up to approximately 2 years | Assessed by BICR and investigators |
| Duration of Response (DOR) per RECIST 1.1 and mRECIST | Up to approximately 2 years | Assessed by BICR and investigators |
Countries
China
Contacts
Primary ContactTing Liu
Outcome results
None listed