Actively Recruiting
Atezolizumab Plus Bevacizumab Alone or Combined with External Beam Radiotherapy for HCC with Macrovascular Invasion
Led by Asan Medical Center · Updated on 2025-02-21
138
Participants Needed
1
Research Sites
175 weeks
Total Duration
On this page
Sponsors
A
Asan Medical Center
Lead Sponsor
S
Seoul National University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Atezolizumab Plus Bevacizumab Alone or Combined with External Beam Radiotherapy for HCC with Macrovascular Invasion
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 20 and 79 years
- Child-Pugh class A liver function
- ECOG performance status of 0 or 1
- Diagnosis of Hepatocellular Carcinoma invading the intrahepatic vascular system
- No prior systemic therapy for Hepatocellular Carcinoma
- At least one measurable tumor lesion 1 cm or larger
- Adequate blood counts: hemoglobin ≥ 9.0 g/dL, neutrophils ≥ 1,000/mm3, platelets ≥ 50,000/mm3 without transfusion
- Total bilirubin ≤ 2.5 mg/dL
You will not qualify if you...
- Prior systemic treatment for Hepatocellular Carcinoma
- Liver transplant recipient
- Peptic ulcer or untreated/incompletely treated varices with bleeding or high risk of bleeding
- Any serious illness or uncontrolled severe medical condition
- History of other treated malignancy within the past two years except Hepatocellular Carcinoma
- Abdominal or pelvic radiotherapy within 28 days before starting study treatment, except palliative bone radiotherapy within 7 days
AI-Screening
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Trial Site Locations
Total: 1 location
1
Asan Medical Center
Seoul, South Korea
Actively Recruiting
Research Team
J
Jihyun An
CONTACT
J
Ju Hyun Shim
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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