RecruitingPhase 3NCT06371157
A Study of AK104+Lenvatinib in Combination With Transarterial Chemoembolization (TACE) Versus TACE in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma
A Phase III, Randomized, Double-blinded, Multicenter Study of Cadonilimab (AK104) + Lenvatinib in Combination With Transarterial Chemoembolization (TACE) Versus TACE in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma
Sponsor
Akeso
Enrollment
469 participants
Start Date
Aug 2, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
A study to evaluate cadonilimab (AK104) + lenvatinib in combination with transarterial chemoembolization (TACE) versus TACE in participants with incurable/non-metastatic hepatocellular carcinoma
Eligibility
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria7
- 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
Exclusion Criteria6
- 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
Interventions
DRUGAK104
intravenous
DRUGLenvatinib
oral
PROCEDURETACE
TACE (chemo and embolic agent injection into the hepatic artery)
OTHERPlacebo for AK104
intravenous
OTHERPlacebo for Lenvatinib
oral
Locations(4)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06371157
Related Trials
Prevention of Variceal Rebleeding by EUS-guided vs Conventional Endoscopic Therapy in Hepatocellular Carcinoma Patients
NCT056298451 location
Prospective Clinical Validation of Next Generation Sequencing (NGS) and Patient-Derived Tumor Organoids (PDO) Guided Therapy in Patients With Advanced/ Inoperable Solid Tumors
NCT060775911 location
Identification of Innovative Biomarkers to Predict Outcomes in Hepatocellular Carcinoma Treated With Tremelimumab and Durvalumab
NCT0679611410 locations
Safety and Efficacy of Cyclophosphamide, Sorafenib, Bevacizumab, and Atezolizumab in Pediatric Solid Tumor Patients
NCT054683592 locations
Evaluation of the Interest to Combine a CD4 Th1-inducer Cancer Vaccine Derived From Telomerase and Atezolizumab Plus Bevacizumab in Unresectable Hepatocellular Carcinoma
NCT0552895214 locations