A Study of AK104+Lenvatinib in Combination With Transarterial Chemoembolization (TACE) Versus TACE in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma
- Conditions
- Hepatocellular Carcinoma
- Interventions
- Registration Number
- NCT06371157
- Lead Sponsor
- Akeso
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 469
- 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)
- No evidence of metastasis
- Not amenable to curative surgery or transplantation or curative ablation but amenable to TACE
- Child Pugh score class A
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment
- Measurable disease by RECIST 1.1
- Adequate organ function
- History of liver transplantation
- History of hepatic encephalopathy
- Uncontrolled arterial hypertension
- Deep venous thrombosis within 3 months before first treatment
- Bleeding events within the last 6 months
- Co-infection with HBV and HCV
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A AK104 AK104+ Lenvatinib in Combination With Transarterial Chemoembolization (TACE) Arm A TACE AK104+ Lenvatinib in Combination With Transarterial Chemoembolization (TACE) Arm B TACE Placebo for AK104 + Placebo for Lenvatinib in Combination With TACE Arm B Placebo for AK104 Placebo for AK104 + Placebo for Lenvatinib in Combination With TACE Arm B Placebo for Lenvatinib Placebo for AK104 + Placebo for Lenvatinib in Combination With TACE Arm C TACE AK104 + Placebo for Lenvatinib in Combination With TACE Arm C Placebo for Lenvatinib AK104 + Placebo for Lenvatinib in Combination With TACE Arm C AK104 AK104 + Placebo for Lenvatinib in Combination With TACE Arm A Lenvatinib AK104+ Lenvatinib in Combination With Transarterial Chemoembolization (TACE)
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Overall Survival (OS) Up to approximately 2 years OS is defined as the time from randomization to death due to any cause.
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
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
Disease Control Rate (DCR) per RECIST 1.1 and mRECIST Up to approximately 2 years Assessed by BICR and investigators
Trial Locations
- Locations (4)
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China
Hunan Cancer Hospital
🇨🇳Changsha, Hunan, China
Zhongda Hospital Southeast University
🇨🇳Nanjing, Jiangsu, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China