TheraSphere Y-90 glass microsphere treatment for liver tumors in Japan
A Prospective Single-arm Study of BSJ019T in Japanese Patients With Unresectable Hepatic Malignancy Who Have Failed or Are Not Eligible for Standard Treatment
This will test whether TheraSphere Y-90 glass microspheres are safe and helpful for Japanese adults with primary or secondary liver cancer who are not candidates for standard treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 51 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Boston Scientific Corporation Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 4 sites (Nishinomiya, Hyōgo and 3 other locations) |
| Trial ID | NCT07377487 on ClinicalTrials.gov |
What this trial studies
This interventional pre-market study delivers TheraSphere Y-90 glass microspheres by transarterial radioembolization to liver tumors in Japanese adults who cannot receive standard therapies. Eligible patients must have measurable, liver-dominant disease with tumor replacement under 50% of total liver volume and an ECOG performance status of 0 or 1. Treatment response will be monitored by CT or MRI using RECIST 1.1 criteria, along with liver function tests and safety surveillance for adverse events. The collected safety and effectiveness data will support consideration of this device for use in this patient population.
Who should consider this trial
Good fit: Adults in Japan with primary or secondary liver cancer that is liver-dominant, measurable on CT/MRI, with tumor replacement <50% of liver volume, ECOG 0–1, and judged by a multidisciplinary board to be ineligible for standard treatments.
Not a fit: Patients with extensive liver involvement (>50% replacement), poor performance status, very limited life expectancy, or disease driven primarily by extrahepatic spread are unlikely to benefit.
Why it matters
Potential benefit: If successful, this could provide a targeted internal radiation option to control liver tumors for patients who lack other standard treatment choices.
How similar studies have performed: Y-90 glass microsphere radioembolization has been used internationally with prior studies showing tumor control and manageable safety, though device-specific data in Japanese patients are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Nishinomiya, Hyōgo and 3 other locations
- Hyogo College of Medicine Hospital — Nishinomiya, Hyōgo, Japan (Not_yet_recruiting)
- Kanazawa University Hospital — Kanazawa, Ishikawa-ken, Japan (Recruiting)
- Kindai University Hospital — Sayama, Osaka, Japan (Not_yet_recruiting)
- National Cancer Center Hospital — Chuo Ku, Tokyo, Japan (Not_yet_recruiting)
Study contacts
- Principal investigator: Koichiro Yamakado, MD, PhD — Hyogo Medical University
- Study coordinator: Satoru Motohashi
- Email: satoru.motohashi@bsci.com
- Phone: +81(80)4619-9640
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.