Liver Neoplasms
Conditions
Keywords
Carcinoma, Carcinoma, Hepatocellular, Neoplasms, Digestive System Neoplasms, Neoplasms, Glandular and Epithelial, Neoplasms by Histologic Type, Neoplasms by Site, Digestive System Diseases, Liver Diseases, Neoplasm Metastasis, Colorectal Neoplasms, Colonic Diseases, Carcinoma, Neuroendocrine, Neuroendocrine Tumors
Brief summary
To investigate the safety and effectiveness of BSJ019T in Japanese patients with primary or secondary liver who are not candidate for standard treatment.
Interventions
DEVICETheraSphere Y-90 glass microsphere
TheraSphere Y-90 glass microsphere therapy administered through the hepatic artery at index procedure.
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
\[
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. | 3-months post index procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical success in delivering the Y-90 microspheres | During the index procedure | Technical success is determined successful if residual waste is ≦2% with optimal tumor targeting and extrahepatic deposition is not seen on post treatment imaging, and the success rate of entire of the subjects will be summarized. |
| Health-related quality of life (HRQoL) using EQ-5D questionnaires at regular intervals | Baseline, 1-, 3- and 6-months post treatment | — |
| Health-related quality of life (HRQoL) using FACT-G questionnaires at regular intervals | Baseline, 1-, 3- and 6-months post treatment | — |
| Overall survival | Through study completion, an average of 1 year | — |
| Rate of objective response (ORR = complete response [CR] or partial response [PR]) at 3 months using the localized RECIST 1.1 criteria and localized mRECIST | 3-months post index procedure | — |
| Rate of hepatic disease control (DCR) and objective response (ORR) at 6 months using localized RECIST 1.1 and localized mRECIST criteria | 6-months post index procedure | — |
| Best response using localized RECIST 1.1 and localized mRECIST criteria. | Through 6-months post index procedure | — |
| Safety assessment: rate of treatment emergent adverse events (TEAEs) of any grade, rate of grade 3 or above TEAEs, rate of SAEs of any causality and rate of SAEs related to treatment with TheraSphere. | Through 6-months post index procedure | All AEs will be evaluated using the standardized grading criteria (National Cancer Institute- Common Terminology Criteria for Adverse Events- Version 5.0 (NCI-CTCAE v 5.0)) |
| Proportion of patient receiving concomitant and post BSJ019T treatment, including subsequent local and systemic anticancer treatment, surgery, intervention and best supportive care. | Through 6-months post index procedure | — |
Countries
Japan
Contacts
CONTACTSatoru Motohashi
PRINCIPAL_INVESTIGATORKoichiro Yamakado, MD, PhD
Hyogo Medical University
Outcome results
None listed