Actively Recruiting
TheraSphere Japan Pre-Market Study
Led by Boston Scientific Corporation · Updated on 2026-04-27
51
Participants Needed
4
Research Sites
101 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To investigate the safety and effectiveness of BSJ019T in Japanese patients with primary or secondary liver who are not candidate for standard treatment.
CONDITIONS
Official Title
TheraSphere Japan Pre-Market Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient aged >18 years at time of consent
- Patient able and willing to participate and provide written informed consent
- Determined by multidisciplinary board to have failed or not be eligible for standard treatment
- Primary or secondary liver cancer diagnosed by histology or imaging
- At least one measurable liver lesion by CT or MRI according to RECIST 1.1
- Liver dominant disease impacting prognosis
- Tumor replaces less than 50% of total liver volume by visual estimation
- Expected life expectancy of 3 months or more from index procedure
- ECOG Performance Status 0 or 1
- Negative pregnancy test in women of child-bearing potential
- Adequate contraception for patient and sexual partner when applicable
- Adequate liver function: Child Pugh A or B7 (HCC), bilirubin ≤2 mg/dL, ALT and AST <5 x ULN, albumin ≥3.0 g/dL
- Adequate renal function: serum creatinine ≤1.5 x ULN
- Adequate hematological function: neutrophil count >1200/mm3, hemoglobin ≥85 mg/L, platelet count >50 x 10^9/L, INR <2.0 or >50% prothrombin activity
- Good PVT targeting and uptake of 99mTc MAA on SPECT/CT after administration if present
- Future liver remnant volume >30% of whole liver volume free of tumor and not planned for treatment
You will not qualify if you...
- Vp4 portal vein tumor thrombosis according to LCSGJ classification
- Severe allergy or intolerance to contrast agents, narcotics, sedatives, or atropine that cannot be managed
- Contraindications to angiography and selective visceral catheterization
- Prior external beam radiation treatment to the liver
- Prior yttrium-90 microsphere treatment to the liver
- Prior peptide receptor radionuclide therapy (PRRT)
- Planned start of systemic anticancer treatment within 3 months after index procedure
- Ongoing adverse events from prior therapy affecting safety evaluation
- Evidence of pulmonary insufficiency or clinically evident chronic obstructive pulmonary disease
- Recent intervention or compromise of Ampulla of Vater within last 3 months or biliodigestive anastomosis
- Presence of ascites beyond trace levels
- Hepatic encephalopathy grade 2 or higher
- Liver function decompensation within last 6 months (ascites, encephalopathy, jaundice)
- Infiltrative disease presentation unsuitable for repeated measurement
- Pregnant or breastfeeding patients unwilling to stop
- Diseases or conditions precluding safe use of BSJ019T including dialysis or unresolved serious infections
- Participation in concurrent clinical or interventional studies
- Conditions preventing participation or study completion as judged by investigator
- Recent gastrointestinal bleeding related to portal hypertension within last 3 months
- Lung radiation dose exceeding safety limits
- Off-target extrahepatic or liver deposition of 99mTc-MAA not correctable by angiography
- Poor tumor perfusion or targeting on CBCT or 99mTc-MAA hepatic arterial scintigraphy leading to inadequate dosing
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
Hyogo College of Medicine Hospital
Nishinomiya, Hyōgo, Japan, 663-8501
Not Yet Recruiting
2
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, Japan, 920-8641
Actively Recruiting
3
Kindai University Hospital
Sayama, Osaka, Japan, 589-8511
Not Yet Recruiting
4
National Cancer Center Hospital
Chuo Ku, Tokyo, Japan, 104-0045
Not Yet Recruiting
Research Team
S
Satoru Motohashi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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