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TheraSphere

Phase 2

Hepatocellular Carcinoma (HCC) | Unknown | Oncology |Boston Scientific Corporation|Last Updated: Jun 17, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment100
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06773845Building Evidence for Ablative Internal Radiation Therapy in Localized HCC Beyond the Up-To-7 CriteriaPHASE2 RECRUITING 100 — — Mar 11, 2025Dec 31, 2029Jun 17, 20254 South Korea
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Study Endpoints
Primary Endpoints
Objective response rate (ORR) according to the mRECIST
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)

The number of patients with partial or complete response accroding to the mRECIST as the best response, divided by the total number of participants (%)

Secondary Endpoints
ORR according to the RECIST 1.1
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)
ORR according to localized mRECIST and RECIST 1.1
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)
Duration of response according to mRECIST, localized mRECIST, and RECIST 1.1
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)
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
RadioembolizationEXPERIMENTALAblative radioembolization using Yttrium-90 glass microspheres
Interventions
NameTypeDescription
TheraSphereDEVICEThe 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).
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Eligibility Criteria
Age Range19 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites4

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: a...

Countries:South Korea
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06773845primaryCompletionDate: changed
LOWMay 24, 2026NCT06773845studyFirstPostDate: changed