Liver NeoplasmsINDIGONCT07377487
TheraSphere Japan Pre-Market Study
A study testing TheraSphere Y-90 glass microsphere in people with Liver Neoplasms, run by Boston Scientific Corporation at 5 sites in Japan.
Trial summary
To investigate the safety and effectiveness of BSJ019T in Japanese patients with primary or secondary liver who are not candidate for standard treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Neoplasms
- What is being tested?
- TheraSphere Y-90 glass microsphere
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 5 sitesJapan
- Study dates
- 22 Jan 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- [Inclusion criteria based on the clinical evaluation]
- 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)
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- 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
- ECOG Performance Status score of 0 or 1
- Negative pregnancy test in women of child-bearing potential
- Adequate contraception for the patient and his/her sexual partner when applicable.
- Adequate liver function, as defined by:
- Child Pugh A or to B7 (HCC)
- Must have bilirubin ≤ 2 mg/dL
- ALT and AST must be <5 x ULN
- Albumin ≥3.0 g/dL
- Adequate renal function, as defined by:
- Serum creatinine must be ≤1.5 x ULN
- Adequate hematological function, as defined by:
- Neutrophil count > 1200 /mm3
- hemoglobin ≥85 mg/L
- platelet count >50 x 109/L
- INR must be <2.0 or >50% prothrombin activity
- [Inclusion Criteria based on the imaging evaluation]
- After 99mTc MAA administration, in SPECT/CT imaging, good PVT targeting and uptake of 99mTc MAA, if present
- Future liver remnant volume (FLRV) >30% of whole liver volume. FRLV is the volume of liver not planned to be treated with TheraSphere and free of tumor
Who cannot join
- [Exclusion Criteria based on the clinical evaluation]
- 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
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- 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.
- Evidence of pulmonary insufficiency or clinically evident chronic obstructive pulmonary disease
- Undergone any intervention for, or compromise of, the Ampulla of Vater within that last 3 months or patient with biliodigestive anastomosis.
- Presence of ascites, clinical or radiological, "trace" of ascites is acceptable.
- Presence of Hepatic encephalopathy (Grade ≥2)
- Previous liver function decompensation within the last 6 months (ascites, encephalopathy, jaundice)
- Patient with infiltrative disease presentation (not suitable for repeated measurement)
- Patients who are pregnant or breast-feeding and does not want to stop.
- Have any disease or condition that would preclude the safe use of BSJ019T, including concurrent dialysis treatment, or unresolved serious infections
- Participating in concurrent clinical studies or interventional clinical studies
- Any condition where the Investigator feels the patient would not be able to participate/finish the study
- Previous gastrointestinal bleeding related to portal hypertension within the last 3 months (preventive treatment is acceptable)
- [Exclusion Criteria based on the imaging evaluation]
- Dose to the lung > 30Gy for a single treatment or cumulative >50 Gy
- Evidence of any off-target extrahepatic and liver deposition on 99mTc-MAA that cannot be corrected using angiographic techniques
- Cone Beam CT (CBCT) or 99mTc-MAA hepatic arterial perfusion scintigraphy shows poor tumor perfusion and/or poor tumor targeting that would lead to a dose that does not meet the liver dosing criteria as specify in the protocol
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Japan5 sites, 5 recruiting
- Recruiting
National Cancer Center Hospital
Chuo Ku, Tokyo, 104-0045
Clinical Trial Office, +81-3-3542-2511, Chiken_CT@ml.res.ncc.go.jp
- Recruiting
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, 920-8641
Clinical Trial Management Section, Hospital Management Div., +81-76-265-2000, irb@adm.kanazawa-u.ac.jp
- Recruiting
Nara Medical University Hospital
Kashihara, Nara
Clinical Trial Office, +81-744-22-3051, chiken-jimunara@naramed-u.ac.jp
- Recruiting
Hyogo College of Medicine Hospital
Nishinomiya, Hyōgo, 663-8501
Hyogo College of Medicine Hospital Clinical Trial Department, +81-798-45-6111, chiken02@hyo-med.ac.jp
- Recruiting
Kindai University Hospital
Sayama, Osaka, 589-8511
Clinical Trial Office, +81-72-366-0221, ck-jimu@med.kindai.ac.jp
About this study
Official title: A Prospective Single-arm Study of BSJ019T in Japanese Patients With Unresectable Hepatic Malignancy Who Have Failed or Are Not Eligible for Standard Treatment
To investigate the safety and effectiveness of BSJ019T in Japanese patients with primary or secondary liver who are not candidate for standard treatment.
- Conditions
- Liver Neoplasms
- Being tested
- TheraSphere Y-90 glass microsphere
- Keywords
- Carcinoma, Carcinoma, Hepatocellular, Neoplasms, Digestive System Neoplasms, Neoplasms, Glandular and Epithelial, Neoplasms by Histologic Type, Neoplasms by Site, Digestive System Diseases, Liver Diseases, Neoplasm Metastasis, Colorectal Neoplasms, Colonic Diseases, Carcinoma, Neuroendocrine, Neuroendocrine Tumors
- Medical subject headings
- Liver Neoplasms, Carcinoma, Carcinoma, Hepatocellular, Neoplasms, Digestive System Neoplasms, Neoplasms, Glandular and Epithelial, Neoplasms by Histologic Type, Neoplasms by Site
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TheraSphere Y-90 glass microsphereDevice
TheraSphere Y-90 glass microsphere therapy administered through the hepatic artery at index procedure.
| Study group | Role | What they receive |
|---|---|---|
| TheraSphere | Experimental | Not described Receives: Device: TheraSphere Y-90 glass microsphere |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3-months post index procedure
Secondary outcomes (9)
Rate of objective response (ORR = complete response [CR] or partial response [PR]) at 3 months using the localized RECIST 1.1 criteria and localized mRECIST
Measured: 3-months post index procedure
Rate of hepatic disease control (DCR) and objective response (ORR) at 6 months using localized RECIST 1.1 and localized mRECIST criteria
Measured: 6-months post index procedure
Best response using localized RECIST 1.1 and localized mRECIST criteria.
Measured: Through 6-months post index procedure
Proportion of patient receiving concomitant and post BSJ019T treatment, including subsequent local and systemic anticancer treatment, surgery, intervention and best supportive care.
Measured: Through 6-months post index procedure
Safety assessment: rate of treatment emergent adverse events (TEAEs) of any grade, rate of grade 3 or above TEAEs, rate of SAEs of any causality and rate of SAEs related to treatment with TheraSphere.
All AEs will be evaluated using the standardized grading criteria (National Cancer Institute- Common Terminology Criteria for Adverse Events- Version 5.0 (NCI-CTCAE v 5.0))
Measured: Through 6-months post index procedure
Technical success in delivering the Y-90 microspheres
Technical success is determined successful if residual waste is ≦2% with optimal tumor targeting and extrahepatic deposition is not seen on post treatment imaging, and the success rate of entire of the subjects will be summarized.
Measured: During the index procedure
Health-related quality of life (HRQoL) using EQ-5D questionnaires at regular intervals
Measured: Baseline, 1-, 3- and 6-months post treatment
Health-related quality of life (HRQoL) using FACT-G questionnaires at regular intervals
Measured: Baseline, 1-, 3- and 6-months post treatment
Overall survival
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start22 Jan 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver NeoplasmsStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Koichiro Yamakado, MD, PhD, Principal investigator, Hyogo Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07377487
- Sponsor's protocol ID
- S2486
- Acronym
- INDIGO
- Status last verified
- Oct 2026
- First submitted
- 24 Sep 2025
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Single-arm Study of BSJ019T in Japanese Patients With Unresectable Hepatic Malignancy Who Have Failed or Are Not Eligible for Standard Treatment
- ClinicalTrials.gov ID
- NCT07377487
- Acronym / sponsor ID
- INDIGO / S2486
- Conditions
- Liver Neoplasms
- Keywords
- Carcinoma, Carcinoma, Hepatocellular, Neoplasms, Digestive System Neoplasms, Neoplasms, Glandular and Epithelial, Neoplasms by Histologic Type, Neoplasms by Site, Digestive System Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 22 Jan 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 30 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the safety and effectiveness of BSJ019T in Japanese patients with primary or secondary liver who are not candidate for standard treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TheraSphere | Experimental | Device: TheraSphere Y-90 glass microsphere |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- [Inclusion criteria based on the clinical evaluation]
- 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)
Key exclusion criteria (24 listed)
- [Exclusion Criteria based on the clinical evaluation]
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TheraSphere Y-90 glass microsphereTheraSphere Y-90 glass microsphere therapy administered through the hepatic artery at index procedure. | Device | TheraSphere |
Primary outcome
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.
Time frame: 3-months post index procedure
9 secondary outcomes
Rate of objective response (ORR = complete response [CR] or partial response [PR]) at 3 months using the localized RECIST 1.1 criteria and localized mRECIST
Time frame: 3-months post index procedure
Rate of hepatic disease control (DCR) and objective response (ORR) at 6 months using localized RECIST 1.1 and localized mRECIST criteria
Time frame: 6-months post index procedure
Best response using localized RECIST 1.1 and localized mRECIST criteria.
Time frame: Through 6-months post index procedure
Proportion of patient receiving concomitant and post BSJ019T treatment, including subsequent local and systemic anticancer treatment, surgery, intervention and best supportive care.
Time frame: Through 6-months post index procedure
Safety assessment: rate of treatment emergent adverse events (TEAEs) of any grade, rate of grade 3 or above TEAEs, rate of SAEs of any causality and rate of SAEs related to treatment with TheraSphere.
Time frame: Through 6-months post index procedure
Technical success in delivering the Y-90 microspheres
Time frame: During the index procedure
Health-related quality of life (HRQoL) using EQ-5D questionnaires at regular intervals
Time frame: Baseline, 1-, 3- and 6-months post treatment
Health-related quality of life (HRQoL) using FACT-G questionnaires at regular intervals
Time frame: Baseline, 1-, 3- and 6-months post treatment
Overall survival
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Koichiro Yamakado, MD, PhD principal investigator
Hyogo Medical University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TheraSphere Y-90 glass microsphere in people with Liver Neoplasms, run by Boston Scientific Corporation at 5 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 27 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Satoru Motohashi (+81(80)4619-9640, satoru.motohashi@bsci.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 3-months post index procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026; AzTrials last refreshed its copy on 27 Oct 2026.