RecruitingPhase 2NCT06773845

Building Evidence for Ablative Internal Radiation Therapy in Localized HCC 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


Sponsor

Seoul National University Hospital

Enrollment

100 participants

Start Date

Mar 11, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

At four major centers in Korea, patients with hepatocellular carcinoma (HCC) that exceed the up-to-7 criteria yet remain locally confined will undergo ablative radioembolization using Yttrium-90 glass microspheres, guided by a standardized dosimetry method. Their treatment response, survival outcomes, and adverse events will be monitored for two years following the procedure.


Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a type of internal radiation treatment (called ablative radioembolization) for people with liver cancer (hepatocellular carcinoma, or HCC) that has grown too large or involves too many tumors for standard surgery or local treatments. The treatment delivers radiation beads directly into the liver's blood vessels to target the tumors. **You may be eligible if...** - You are 19 years or older - You have liver cancer confirmed by biopsy or imaging - Your cancer is in the liver only (not spread outside) and affects between 1 and 5 neighboring liver sections - Your liver function is relatively good (Child-Pugh class A) - You are generally active and able to care for yourself (ECOG score 0–1) - Enough healthy liver tissue would remain after treatment **You may NOT be eligible if...** - Your cancer has spread outside the liver - Your liver function is significantly impaired - You have previously had HCC in the part of the liver that would remain after treatment - Your blood counts or organ function do not meet the required levels Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICETheraSphere

The multicompartment MIRD model (a.k.a. partition model) based on diagnostic CT/MRI and 99mTc-MAA SPECT-CT will be used to plan a targeted dose of 700 Gy (± 50%) to the tumor. Given the high tumor burden, a scheduled second radioembolization within 120 days from the initial treatment will be permitted at the discretion of the operators provided the cumulative lung dose remains below 50 Gy. A scheduled second radioembolization may be considered when the largest tumor diameter exceeds 8 cm, or the estimated lung dose reaches 30 Gy while the tumor absorbed dose remains below the target dose of 700 Gy. The radioactive microsphere delivery device used will be glass-based (TheraSphere; Boston Scientific, MA, USA), in which Y90 is an integral constituent of the biocompatible glass matrix. Dosimetry planning will be made by personalized dosimetry software (Simplicit90y; Boston Scientific).


Locations(4)

National Cancer Center

Ilsan, Gyeonggi-do, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

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NCT06773845


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