RecruitingNot ApplicableNCT07377487

TheraSphere Japan Pre-Market Study

A Prospective Single-arm Study of BSJ019T in Japanese Patients With Unresectable Hepatic Malignancy Who Have Failed or Are Not Eligible for Standard Treatment


Sponsor

Boston Scientific Corporation

Enrollment

51 participants

Start Date

Jan 22, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates TheraSphere, a liver-targeted radiation therapy using tiny radioactive beads (yttrium-90 microspheres) delivered directly to liver tumors, in Japanese patients with primary or secondary liver cancer who have not responded to or are not eligible for standard treatments. **You may be eligible if...** - You are over 18 with primary or secondary liver cancer confirmed by imaging or biopsy - Your cancer has not responded to or you are not eligible for standard therapies - Your liver tumor occupies less than 50% of total liver volume - Your liver, kidney, and blood function meet required thresholds - Your life expectancy is at least 3 months - You are in generally good overall health (ECOG 0–1) **You may NOT be eligible if...** - You have received prior liver radiation therapy or yttrium-90 treatment - You have significant fluid buildup in your abdomen (ascites) or liver confusion (encephalopathy grade 2+) - You have active serious infections or are undergoing dialysis - You are pregnant or breastfeeding - You have had bleeding from stomach veins related to liver pressure in the past 3 months - You are participating in another clinical study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICETheraSphere Y-90 glass microsphere

TheraSphere Y-90 glass microsphere therapy administered through the hepatic artery at index procedure.


Locations(4)

Hyogo College of Medicine Hospital

Nishinomiya, Hyōgo, Japan

Kanazawa University Hospital

Kanazawa, Ishikawa-ken, Japan

Kindai University Hospital

Sayama, Osaka, Japan

National Cancer Center Hospital

Chuo Ku, Tokyo, Japan

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NCT07377487


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