TheraSphere Radioactive Beads for Liver Tumors That Cannot Be Treated Surgically

Trial details

Who runs it

Boston Scientific Corporation

Trial code

NCT07377487

Record updated

21 October 2026

Original description

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

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.

Inclusion: [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: 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); 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; Previous liver function decompensation within the last 6 months (ascites, encephalopathy, jaundice); 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; Previous gastrointestinal bleeding related to portal hypertension within the last 3 months (preventive treatment is acceptable); [Exclusion Criteria based on the imaging 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; Evidence of pulmonary insufficiency or clinically evident chronic obstructive pulmonary disease; Patient with infiltrative disease presentation (not suitable for repeated measurement); Any condition where the Investigator feels the patient would not be able to participate/finish the study; [Exclusion Criteria based on the clinical evaluation]; Contraindications to angiography and selective visceral catheterization; Plan to start systemic anticancer treatment in the next 3 month after the index procedure; 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); Patients who are pregnant or breast-feeding and does not want to stop; 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.

ClinicalTrials.gov NCT07377487