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 range18 Years

SexALL

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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.
✕. Contraindications to angiography and selective visceral catheterization
✕. Received any prior external beam radiation treatment to the liver
✕. Received any prior yttrium-90 microsphere treatment to the liver
✕. Received previous peptide receptor radionuclide therapy (PRRT)
✕. Plan to start systemic anticancer treatment in the next 3 month after the index procedure.
✕. Presence of ongoing adverse event due to prior therapy as judged by the principal investigator or sub-investigator to affect the safety evaluation of the study device.

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