Status:
RECRUITING
Atezolizumab Plus Bevacizumab Alone or Combined with External Beam Radiotherapy for HCC with Macrovascular Invasion
Lead Sponsor:
Asan Medical Center
Collaborating Sponsors:
Seoul National University Hospital
Hanyang University Guri Hospital
Conditions:
Hepatocellular Carcinoma
Hepatocellular Cancer
Eligibility:
All Genders
20-79 years
Phase:
PHASE2
Brief 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 ove...
Detailed Description
A total of 138 subjects are randomly assigned to one of two treatment groups (69 patients in the atezolizumab+bevacizumab group and 69 patients in the Atezolizumab plus Bevacizumab combined EBRT group...
Eligibility Criteria
Inclusion
- 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
- No prior systemic therapy for HCC
- At least one measurable HCC lesion with ≥ 1cm diameter
- Adequate hematologic and organ function
- Hemoglobin ≥ 9.0 g/dL
- Absolute neutrophil count ≥ 1,000 /mm3
- Platelet ≥ 50,000/ mm3 without transfusion
- Total bilirubin ≤ 2.5 mg/dL
Exclusion
- 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
- A history of treated malignancy (other than HCC) is allowable if the patient's malignancy has been in complete remission, off chemotherapy and without additional surgical intervention, during the preceding two years
- Abdominal/pelvic radiotherapy within 28 days prior to initiation of study treatment, except palliative radiotherapy to bone lesions within 7 days prior to initiation of study treatment
Key Trial Info
Start Date :
October 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT05992220
Start Date
October 22 2022
End Date
March 1 2026
Last Update
February 21 2025
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea