Building Evidence for Ablative Internal Radiation Therapy in Localized HCC Beyond the Up-To-7 Criteria

PHASE2RecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

March 11, 2025

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2029

Conditions
Hepatocellular Carcinoma (HCC)Radioembolization
Interventions
DEVICE

TheraSphere

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).

Trial Locations (4)

10408

RECRUITING

National Cancer Center, Ilsan

03080

RECRUITING

Seoul National University Hospital, Seoul

03722

RECRUITING

Severance Hospital, Seoul

06351

RECRUITING

Samsung Medical Center, Seoul

Sponsors
All Listed Sponsors
collaborator

Boston Scientific Corporation

INDUSTRY

lead

Seoul National University Hospital

OTHER