TheraSphere Japan Pre-Market Study

Inclusion criteria

[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)
• 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

Exclusion criteria

[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
• 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