About this trial
The recent global IMbrave150 study evaluated the combination of atezolizumab and bevacizumab versus sorafenib in 501 patients with advanced or metastatic Hepatocellular Carcinoma (HCC). The median overall survival (OS) was notably better in the atezolizumab/bevacizumab group. However, for HCC patients with intrahepatic macrovascular invasion (MVI), the prognosis remains poor, indicating a significant unmet need in this group.
External Beam Radiotherapy (EBRT) has shown promising results in treating HCC with MVI, especially when used in combination with trans-arterial chemoembolization (TACE). It has been reported that radiotherapy may make tumor cells more susceptible to immune-mediated therapy, potentially enhancing the effects of atezolizumab and bevacizumab.
Thus, this study aims to investigate the efficacy and safety of atezolizumab/bevacizumab alone versus atezolizumab/bevacizumab in combination with EBRT in HCC patients with macrovascular invasion.
Eligibility criteria
Qualifiers
Older than 19 years of age, lower than 80 years of age
Child-Pugh class A hepatic function
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1
Patients with HCC [diagnosed according to AASLD guidelines] invading the intrahepatic vascular system
Disqualifiers
Treatment history of prior systemic treatment of HCC
Liver transplant recipients
Patients with peptic ulcer, untreated or incompletely treated varices with bleeding or high-risk for bleeding
Any serious illness (e.g., active infection or inflammatory condition) or uncontrolled severe medical comorbidity
Trial design
Treatments tested in this trial
- Atezolizumab plus bevacizumab, combined EBRT to vascular invasion
- Atezolizumab plus bevacizumab
Treatment groups
Sponsors and collaborators
Asan Medical Center
Lead sponsor
Seoul National University Hospital
Collaborator
Hanyang University Guri Hospital
Collaborator
Soon Chun Hyang University
Collaborator