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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
TheraSphere
DeviceThe 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).
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: RadioembolizationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Objective response rate (ORR) according to the mRECIST
The number of patients with partial or complete response accroding to the mRECIST as the best response, divided by the total number of participants (%)
Time frame
Time of treatment up to subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled)Secondary outcomes
1
ORR according to the RECIST 1.1
The number of patients with partial or complete response according to the RECIST 1.1 as the best response, divided by the total number of participants (%)
Time frame
Time of treatment up to subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled)2
ORR according to localized mRECIST and RECIST 1.1
The number of patients with partial or complete response as the best response, divided by the total number of participants (%). In the localized mRECIST and RECIST 1.1, the tumor response is assessed only within radioembolization-treated area.
Time frame
Time of treatment up to subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled)3
Duration of response according to mRECIST, localized mRECIST, and RECIST 1.1
The time from the first documentation of partial or complete response to the first occurrence of progressive disease, death from any cause, or receipt of subsequent anticancer treatment, whichever comes first.
Time frame
Time of response up to progression, subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled)4
Overall survival rate
Time frame
Time of treatment up to participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Seoul National University Hospital
Lead sponsor
Boston Scientific Corporation
Collaborator
Source ClinicalTrials.gov