TheraSphere Japan Pre-Market Study

NCT07377487 | Recruiting

• 1 other identifier: S2486
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 4

Brief Summary

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

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

Outcome Measures

Primary Outcomes (1)

• 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 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

  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.

  Through 6-months post index procedure

Study Arms (1)

TheraSphere

EXPERIMENTAL

Device: TheraSphere Y-90 glass microsphere

Interventions

TheraSphere Y-90 glass microsphere DEVICE

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

TheraSphere

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (4)

Hyogo College of Medicine Hospital

Nishinomiya, Hyōgo, 663-8501, Japan

NOT YET RECRUITING

Kanazawa University Hospital

Kanazawa, Ishikawa-ken, 920-8641, Japan

RECRUITING

Kindai University Hospital

Sayama, Osaka, 589-8511, Japan

NOT YET RECRUITING

National Cancer Center Hospital

Chuo Ku, Tokyo, 104-0045, Japan

NOT YET RECRUITING

MeSH Terms

Conditions

Liver Neoplasms; 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

Condition Hierarchy (Ancestors)

Adenocarcinoma; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue

Study Officials

• Koichiro Yamakado, MD, PhD

  Hyogo Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Satoru Motohashi

CONTACT

+81(80)4619-9640; satoru.motohashi@bsci.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: January 30, 2026
• Study Start: January 22, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

JP (4)