Clinical Trial

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

Study acronym: ALERT-HCC
Recruiting Phase 2
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Record status
This record was last updated February 21, 2025 (before its estimated March 2026 completion). Its status may not reflect the trial's current state.
Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2023-08-07.
Trial Details
NCT Number NCT05992220
Lead Sponsor Asan Medical Center
Collaborators: Seoul National University Hospital, Hanyang University Guri Hospital, Soon Chun Hyang University
Conditions Hepatocellular Carcinoma, Hepatocellular Cancer, Hepatocellular Carcinoma Non-resectable, Hepatocellular Carcinoma Stage IV, Liver Cancer
Enrollment 138 participants
Start Date 2022-10-22
Primary Completion 2026-03 (estimated)
Study Completion 2026-03 (estimated)
Updated on ClinicalTrials.gov 2025-02-21