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New treatment option for Hepatocellular Carcinoma
Official title Atezolizumab Plus Bevacizumab Alone or Combined with External Beam Radiotherapy for HCC with Macrovascular Invasion
ClinicalTrials.gov ID: NCT05992220
What this study is testing
What is Atezolizumab plus bevacizumab?
Atezolizumab plus bevacizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hepatocellular carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 to 79
You may be able to join if
- 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
You likely can't join if
- 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...
- Abdominal/pelvic radiotherapy within 28 days prior to initiation of study treatment, except palliative radiotherapy to bone lesions within 7 days...
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years to 79 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.