Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Cancer | Hepatocellular Carcinoma | CURATED_BROADER | 0.80 |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Hepatocellular Carcinoma Non-resectable | Liver Neoplasm | PROBABILISTIC | 0.70 |
| Hepatocellular Carcinoma Stage IV | Hepatocellular Carcinoma | CURATED_BROADER | 0.78 |
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Atezolizumab plus bevacizumab | Drug | — | UNRESOLVED |
| Atezolizumab plus bevacizumab, combined EBRT to vascular invasion | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Radiotherapy combination
- description
- Atezolizumab+Bevacizumab, combined EBRT to vascular invasion * Atezolizumab will be administered by IV, 1200 mg on day 1 of each 21day cycle. * Bevacizumab will be administered by IV, 15 mg/kg on day 1 of each 21day cycle. * The external beam radiotherapy will commence after day 2 of the first cycle of A+B, and will be delivered in accordance with institutional protocol.
- interventionNames
- Radiation: Atezolizumab plus bevacizumab, combined EBRT to vascular invasion
- type
- ACTIVE_COMPARATOR
- label
- Atezolizumab+Bevacizumab
- description
- * Atezolizumab will be administered by IV, 1200 mg on day 1 of each 21day cycle. * Bevacizumab will be administered by IV, 15 mg/kg on day 1 of each 21day cycle.
- interventionNames
- Drug: Atezolizumab plus bevacizumab
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 79 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available