Atezolizumab Plus Bevacizumab Alone or Combined with External Beam Radiotherapy for HCC with Macrovascular Invasion

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age20-79
SponsorAsan Medical Center

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

138 Participants
are divided into 2 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