Ablative radioembolization for localized hepatocellular carcinoma beyond the Up-To-7 criteria

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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).

Why it matters

Who can join: the full rules

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 it's running

• Gangneung Asan Hospital
  Gangneung, Gangwon-do, South Korea Recruiting
• Hallym University Sacred Heart Hospital
  Anyang-si, Gyeonggi-do, South Korea Recruiting
• National Cancer Center
  Ilsan, Gyeonggi-do, South Korea Recruiting
• Seoul National University Bundang Hospital
  Seongnam-si, Gyeonggi-do, South Korea Recruiting
• Seoul National University Hospital
  Seoul, South Korea Recruiting
• Severance Hospital
  Seoul, South Korea Recruiting

Study contacts

• Study coordinator: Hyun Hee Lee
• Email: redlion55@snu.ac.kr
• Phone: +82 220724177

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Biomarker testing to predict treatment response and recurrence in liver cancer

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• MRI plus diffusion and CEST imaging to map liver cancer and its immune environment

  This study tests whether adding an extra MRI sequence can help see how the liver cancer microenvironment changes and relate those changes to immune activity in patients with hepatocellular carcinoma.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.