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

Launched by ASAN MEDICAL CENTER · Aug 7, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a combination treatment for patients with advanced liver cancer, specifically Hepatocellular Carcinoma (HCC) that has spread into the blood vessels within the liver. Researchers want to find out if using two drugs, atezolizumab and bevacizumab, along with a type of radiation therapy called External Beam Radiotherapy (EBRT), can improve outcomes for patients with this difficult-to-treat condition. Previous studies have shown that the drug combination helps patients live longer, but those with significant blood vessel involvement still face challenges. This trial aims to see if adding radiation therapy can enhance the effectiveness of the drug treatment.

Eligible participants for this trial are adults aged 19 to 79 with specific liver function and performance status requirements. They should have measurable liver tumors and have not received prior treatment for their cancer. Participants can expect to receive either the drug combination alone or the drug combination with radiation therapy, and they will be closely monitored for any side effects and the overall effectiveness of the treatment. It's important to note that those with certain health conditions, previous treatments, or recent surgeries may not qualify for this study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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