Patients with primary or secondary liver who are not candidate for standard treatment
Conditions
Interventions
Y-90 glass microsphere therapy administered through the hepatic artery
Sponsors
Kazuo Kawahara
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [Inclusion criteria based on the clinical evaluation] 1.Patient aged 18 years or older 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 less than 50% of total liver volume based on visual estimation by the investigator 8.Expected life expectancy at least 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 13.Adequate renal function 14.Adequate hematological function [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% or greater 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: [Exclusion Criteria based on the clinical evaluation] 1.Vp4 according to the Liver Cancer Study Group of Japan (LCSGJ) portal vein tumor thrombosis classification 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 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 over 30Gy for a single treatment or cumulative over 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Contacts
Public ContactSatoru Motohashi
Boston Scientific Japan K.K.
Outcome results
None listed