Ablative radioembolization for localized hepatocellular carcinoma beyond the Up-To-7 criteria
Building Evidence for Ablative Internal Radiation Therapy Using Yttrium-90 Glass Microspheres in Localized Hepatocellular Carcinoma Beyond the Up-To-7 Criteria
This study is testing a new treatment using Yttrium-90 glass microspheres for people with localized liver cancer that doesn't meet certain criteria to see if it helps shrink tumors and improve survival.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Seoul National University Hospital Academic / other |
| Drugs / interventions | Radiation |
| Locations | 4 sites (Ilsan, Gyeonggi-do and 3 other locations) |
| Trial ID | NCT06773845 on ClinicalTrials.gov |
What this trial studies
This phase II clinical trial evaluates the efficacy and safety of ablative radioembolization using Yttrium-90 glass microspheres in patients with hepatocellular carcinoma (HCC) that exceeds the Up-To-7 criteria but remains localized. Conducted at four major centers in Korea, the study employs a personalized dosimetry approach to target a tumor dose of 700 Gy. Patients will be monitored for treatment response, survival outcomes, and adverse events over a two-year period, with evaluations including laboratory tests and imaging. The primary endpoint is the objective response rate assessed by modified Response Evaluation Criteria in Solid Tumors (mRECIST).
Who should consider this trial
Good fit: Ideal candidates include adults aged 19 and over with unresectable HCC beyond the Up-To-7 criteria, confined to one to five adjacent Couinaud segments.
Not a fit: Patients with major organ dysfunction or those with current or previous HCC in the untreated liver may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced localized HCC who do not meet traditional treatment criteria.
How similar studies have performed: Other studies have shown promising results with radioembolization approaches, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ilsan, Gyeonggi-do and 3 other locations
- National Cancer Center — Ilsan, Gyeonggi-do, South Korea (Recruiting)
- Seoul National University Hospital — Seoul, South Korea (Recruiting)
- Severance Hospital — Seoul, South Korea (Recruiting)
- Samsung Medical Center — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Hyun Hee Lee
- Email: redlion55@snu.ac.kr
- Phone: +82 220724177
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.