Combining Atezolizumab and Bevacizumab with Radiotherapy for Advanced Liver Cancer
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)
This study is testing if combining two cancer drugs with radiation therapy can help people with advanced liver cancer feel better and improve their treatment outcomes.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 138 (estimated) |
| Ages | 20 Years to 79 Years |
| Sex | All |
| Sponsor | Asan Medical Center Academic / other |
| Drugs / interventions | chemotherapy, atezolizumab, bevacizumab |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05992220 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness and safety of the combination of atezolizumab and bevacizumab, with and without external beam radiotherapy, in patients with hepatocellular carcinoma (HCC) that has macrovascular invasion. A total of 138 participants will be randomly assigned to receive either the drug combination alone or the drug combination alongside radiotherapy. The study aims to determine if adding radiotherapy enhances the treatment's efficacy for this challenging patient population. The treatment regimen involves administering atezolizumab and bevacizumab intravenously in 21-day cycles, with radiotherapy starting shortly after the first cycle.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 19 to 80 with Child-Pugh class A hepatic function and measurable hepatocellular carcinoma lesions.
Not a fit: Patients who have received prior systemic therapy for HCC or have serious comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival outcomes for patients with advanced liver cancer and macrovascular invasion.
How similar studies have performed: Previous studies have shown promising results with similar combinations of immunotherapy and radiotherapy, suggesting potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seoul
- Asan Medical Center — Seoul, South Korea (Recruiting)
Study contacts
- Principal investigator: Ju Hyun Shim — Asan Medical Center
- Study coordinator: Jihyun An
- Email: starlit1@naver.com
- Phone: 82-31-560-2209
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.