Building Evidence for Ablative Internal Radiation Therapy in Localized HCC Beyond the Up-To-7 Criteria
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age19+
SponsorSeoul National University Hospital
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
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
Trial design
Treatments tested in this trial
- TheraSphere
Treatment groups
100 Participants
are divided into 1 treatment groupSponsors and collaborators
Seoul National University Hospital
Lead sponsor
Boston Scientific Corporation
Collaborator
Source ClinicalTrials.gov