TheraSphere Japan Pre-Market Study (INDIGO)

Boston Scientific

Status: Enrolling

Conditions: Liver Neoplasms

Treatments: Device: TheraSphere Y-90 glass microsphere

Study type: Interventional

Funder types: Industry

Identifiers

NCT07377487

S2486

Details and patient eligibility

About

To investigate the safety and effectiveness of BSJ019T in Japanese patients with primary or secondary liver who are not candidate for standard treatment.

Enrollment: 51 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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51 participants in 1 patient group

TheraSphere

Experimental group

Treatment:

Device: TheraSphere Y-90 glass microsphere