Building Evidence for Ablative Internal Radiation Therapy in Localized HCC Beyond the Up-To-7 Criteria

Launched by SEOUL NATIONAL UNIVERSITY HOSPITAL · Jan 12, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a treatment called ablative radioembolization for patients with a type of liver cancer known as hepatocellular carcinoma (HCC). Specifically, it focuses on patients whose cancer is larger or more extensive than what’s typically allowed (beyond the "up-to-7" criteria) but is still localized, meaning it hasn't spread to other parts of the body. The treatment involves using tiny glass beads containing a radioactive substance, which are delivered directly to the tumor to help shrink it. Researchers will track how well the treatment works, how long patients survive afterward, and any side effects they may experience over two years.

To be eligible for this trial, patients must be at least 19 years old and have a confirmed diagnosis of HCC that is not removable through surgery. They should have no other active liver cancer in the untreated parts of their liver and should have enough healthy liver tissue remaining for future function. Additionally, they need to meet certain health criteria, such as having stable blood test results. Participants can expect to receive this innovative treatment at one of four major centers in Korea and will be closely monitored by healthcare professionals throughout the trial. If you or someone you know is interested, it's essential to discuss eligibility with a healthcare provider.

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Eligibility criteria

• • Inclusion criteria
• • Adult aged 19 and over
• • HCC diagnosed by histology or non-invasive criteria of the American Association for the Study of Liver Disease
• • Unresectable HCC beyond the UT7 criteria: the sum of the diameter of the largest tumor (cm) and the number of tumors \> 7
• • Localized HCC: all tumors are in the one to five geographically adjacent Couinaud segments
• • No current or previous HCC in the untreated liver (i.e., future liver remnant \[FLR\])
• • FLR volume \> 30% of total non-tumorous liver volume
• • Child-Pugh class A
• • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
• * No major organ dysfunction according to blood test performed within two months of study enrollment:
• • Leukocytes ≥ 2,000/µL and ≤ 15,000/µL
• • Hemoglobin ≥ 8.0 g/dL (transfusion allowed to meet this criterion)
• • Total bilirubin ≤ 2.0 mg/dL
• • Platelet ≥ 40,000/µL
• • International normalized ratio (INR) ≤ 2.0 for patients not taking anticoagulants
• • Aspartate transaminase (AST) ≤ 200 IU/L (i.e., ≤ 5X upper normal limit)
• • Alanine transaminase (ALT) ≤ 200 IU/L (i.e., ≤ 5X upper normal limit)
• • Creatinine ≤ 2.5 mg/dL
• • Patients with a life expectancy of more than 3 months
• • For women of childbearing age, a negative serum pregnancy test
• • Patients who have adequately understood the clinical trial and consented in writing
• Exclusion Criteria:
• • HCC with vascular invasion and/or bile duct invasion on dynamic computed tomography (CT) or magnetic resonance imaging (MRI)
• • HCC with extrahepatic spread on chest CT and abdominal CT or MRI
• • Multinodular disseminated HCC: largest tumor size \< 6 cm, or number of tumors \> 10
• * Patients who are not suitable for ablative radioembolization as indicated by pre-treatment mapping with 99mTc-macroaggregated albumin (MAA):
• • Cases where the estimated lung dose exceeds 30 Gy when 350 Gy of tumor absorbed dose is administered to the tumor based on the multicompartment Medical Internal Radiation Dose (MIRD) model
• • Cases with severe hepatic artery-portal vein shunting that might lead to irradiation of the non-tumorous liver segments
• • Cases where the operator determines that there is substantial adhesion with the surrounding organs such as the bowel, making ablative radioembolization infeasible
• • Cases where the operator judges that the occurrence of even mild radiation pneumonitis could be fatal, based on marked emphysema or interstitial lung disease findings on chest CT
• • Patients who have had active cancer within the last two years prior to the study enrollment
• • History of severe allergy of intolerance to contrast agents
• • Contraindication to angiography or selective visceral catheterization