TheraSphere Japan Pre-Market Study (INDIGO)

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.

Study Overview

• Status: Recruiting
• Conditions: Liver Neoplasms
• Intervention / Treatment: Device: TheraSphere Y-90 glass microsphere

• Study Type: Interventional
• Enrollment (Estimated): 51
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Satoru Motohashi; Phone Number: +81(80)4619-9640; Email: satoru.motohashi@bsci.com

Study Locations

• Japan
  • Hyōgo
    • Nishinomiya, Hyōgo, Japan, 663-8501
      • Not yet recruiting
      • Hyogo College of Medicine Hospital
      • Contact: Hyogo College of Medicine Hospital Clinical Trial Department; Phone Number: +81-798-45-6111; Email: chiken02@hyo-med.ac.jp
  • Ishikawa-ken
    • Kanazawa, Ishikawa-ken, Japan, 920-8641
      • Recruiting
      • Kanazawa University Hospital
      • Contact: Clinical Trial Management Section, Hospital Management Div.; Phone Number: +81-76-265-2000; Email: irb@adm.kanazawa-u.ac.jp
  • Osaka
    • Sayama, Osaka, Japan, 589-8511
      • Not yet recruiting
      • Kindai University Hospital
      • Contact: Clinical Trial Office; Phone Number: +81-72-366-0221; Email: ck-jimu@med.kindai.ac.jp
  • Tokyo
    • Chuo Ku, Tokyo, Japan, 104-0045
      • Not yet recruiting
      • National Cancer Center Hospital
      • Contact: Clinical Trial Office; Phone Number: +81-3-3542-2511; Email: Chiken_CT@ml.res.ncc.go.jp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

[Inclusion criteria based on the clinical evaluation]

1. Patient aged >18 years at time of consent
2. Patient is able and willing to participate in the study and has provided written informed consent
3. Patient who is determined to have failed or not be eligible for standard treatment by the multidisciplinary board
4. Primary or secondary liver cancer (by histology or imaging)
5. Measurable disease defined as at least one uni-dimensional measurable liver lesion by CT/MRI (according to RECIST 1.1)
6. Liver dominant disease (patient prognosis is driven by liver tumor)
7. Tumor replacement <50% of total liver volume based on visual estimation by the investigator
8. Expected life expectancy ≥ 3 months or more from the index procedure
9. ECOG Performance Status score of 0 or 1
10. Negative pregnancy test in women of child-bearing potential
11. Adequate contraception for the patient and his/her sexual partner when applicable.

12. 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

13. Adequate renal function, as defined by:

    • Serum creatinine must be ≤1.5 x ULN

14. 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]

15. After 99mTc MAA administration, in SPECT/CT imaging, good PVT targeting and uptake of 99mTc MAA, if present
16. 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

Exclusion Criteria:

[Exclusion Criteria based on the clinical evaluation]

1. Vp4 according to the Liver Cancer Study Group of Japan (LCSGJ) portal vein tumor thrombosis classification1
2. History of severe allergy or intolerance to contrast agents, narcotics sedatives or atropine that cannot be managed medically.
3. Contraindications to angiography and selective visceral catheterization
4. Received any prior external beam radiation treatment to the liver
5. Received any prior yttrium-90 microsphere treatment to the liver
6. Received previous peptide receptor radionuclide therapy (PRRT)
7. Plan to start systemic anticancer treatment in the next 3 month after the index procedure.
8. 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.
9. Evidence of pulmonary insufficiency or clinically evident chronic obstructive pulmonary disease
10. Undergone any intervention for, or compromise of, the Ampulla of Vater within that last 3 months or patient with biliodigestive anastomosis.
11. Presence of ascites, clinical or radiological, "trace" of ascites is acceptable.
12. Presence of Hepatic encephalopathy (Grade ≥2)
13. Previous liver function decompensation within the last 6 months (ascites, encephalopathy, jaundice)
14. Patient with infiltrative disease presentation (not suitable for repeated measurement)
15. Patients who are pregnant or breast-feeding and does not want to stop.
16. Have any disease or condition that would preclude the safe use of BSJ019T, including concurrent dialysis treatment, or unresolved serious infections
17. Participating in concurrent clinical studies or interventional clinical studies
18. Any condition where the Investigator feels the patient would not be able to participate/finish the study

19. Previous gastrointestinal bleeding related to portal hypertension within the last 3 months (preventive treatment is acceptable)

    [Exclusion Criteria based on the imaging evaluation]

20. Dose to the lung > 30Gy for a single treatment or cumulative >50 Gy
21. Evidence of any off-target extrahepatic and liver deposition on 99mTc-MAA that cannot be corrected using angiographic techniques
22. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TheraSphere	Device: TheraSphere Y-90 glass microsphere; TheraSphere Y-90 glass microsphere therapy administered through the hepatic artery at index procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	3-months post index procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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		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		6-months post index procedure
Best response using localized RECIST 1.1 and localized mRECIST criteria.		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.		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))	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.	During the index procedure
Health-related quality of life (HRQoL) using EQ-5D questionnaires at regular intervals		Baseline, 1-, 3- and 6-months post treatment
Health-related quality of life (HRQoL) using FACT-G questionnaires at regular intervals		Baseline, 1-, 3- and 6-months post treatment
Overall survival		Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Koichiro Yamakado, MD, PhD, Hyogo Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: September 24, 2025
• First Submitted That Met QC Criteria: January 26, 2026
• First Posted (Actual): January 30, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Carcinoma; Neoplasms; Digestive System Diseases; Liver Diseases; Carcinoma, Hepatocellular; Colorectal Neoplasms; Colonic Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms by Site; Digestive System Neoplasms; Neuroendocrine Tumors; Neoplasm Metastasis; Carcinoma, Neuroendocrine
• Additional Relevant MeSH Terms: Pathologic Processes; Intestinal Diseases; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Adenocarcinoma; Neoplastic Processes; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Pathological Conditions, Signs and Symptoms; Neoplasms; Digestive System Diseases; Colonic Diseases; Carcinoma; Carcinoma, Hepatocellular; Colorectal Neoplasms; Neoplasm Metastasis; Liver Neoplasms; Neuroendocrine Tumors; Liver Diseases; Carcinoma, Neuroendocrine; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Neoplasms by Site
• Other Study ID Numbers: S2486

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No