RecruitingNot Applicable

TheraSphere Japan Pre-Market Study

Japan51 participantsStarted 2026-01-22

Plain-language summary

To investigate the safety and effectiveness of BSJ019T in Japanese patients with primary or secondary liver who are not candidate for standard treatment.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patient aged \>18 years at time of consent
. Patient is able and willing to participate in the study and has provided written informed consent
. Patient who is determined to have failed or not be eligible for standard treatment by the multidisciplinary board
. Primary or secondary liver cancer (by histology or imaging)
. Measurable disease defined as at least one uni-dimensional measurable liver lesion by CT/MRI (according to RECIST 1.1)
. Liver dominant disease (patient prognosis is driven by liver tumor)
. Tumor replacement \<50% of total liver volume based on visual estimation by the investigator
. Expected life expectancy ≥ 3 months or more from the index procedure

Exclusion criteria

. Vp4 according to the Liver Cancer Study Group of Japan (LCSGJ) portal vein tumor thrombosis classification1
. History of severe allergy or intolerance to contrast agents, narcotics sedatives or atropine that cannot be managed medically.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Rate of hepatic disease control (DCR = complete response [CR], partial response [PR] or stable disease [SD]) at 3 months using the localized RECIST 1.1 criteria.

Timeframe: 3-months post index procedure

Trial details

NCT IDNCT07377487

SponsorBoston Scientific Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-06-30

Contact for this trial

Satoru Motohashi

+81(80)4619-9640 satoru.motohashi@bsci.com

View on ClinicalTrials.gov More Liver Neoplasms trials