NCT05992220 Atezolizumab Plus Bevacizumab Alone or Combined with External Beam Radiotherapy for HCC with Macrovascular Invasion
| NCT ID | NCT05992220 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Asan Medical Center |
| Condition | Hepatocellular Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 138 participants |
| Start Date | 2022-10-22 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 138 participants in total. It began in 2022-10-22 with a primary completion date of 2026-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Ju Hyun Shim
PRINCIPAL INVESTIGATOR
Asan Medical Center
Frequently Asked Questions
Who can join the NCT05992220 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 79 Years, studying Hepatocellular Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05992220 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05992220 currently recruiting?
Yes, NCT05992220 is actively recruiting participants. Contact the research team at starlit1@naver.com for enrollment information.
Where is the NCT05992220 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT05992220 clinical trial?
NCT05992220 is sponsored by Asan Medical Center. The principal investigator is Ju Hyun Shim at Asan Medical Center. The trial plans to enroll 138 participants.
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