NCT05992220RecruitingPhase 2
Atezolizumab Plus Bevacizumab Alone or Combined with External Beam Radiotherapy for HCC with Macrovascular Invasion
A Randomized, Multicenter, Open-Label, Phase II Trial of Atezolizumab Plus Bevacizumab Alone or Combined with External Beam RadioTherapy for HepatoCellular Carcinoma with Macrovascular Invasion (ALERT-HCC)
Source: ClinicalTrials.gov · Last updated 21 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 138 (estimated)
- First submitted
- 27 Jul 2023
- Start date
- 22 Oct 2022
- Primary completion date
- Mar 2026
- Lead sponsor
- Asan Medical Center
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT05992220
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 138
- From 22 Oct 2022 to the primary completion date, Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment history of prior systemic treatment of HCC
- Liver transplant recipients
- 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
Other illness
- 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
Who the study is looking for
- 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
Age in the registry: 20 years to 79 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.