To investigate the safety and effectiveness of BSJ019T in Japanese patients with primary or secondary liver who are not candidate for standard treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
51
TheraSphere Y-90 glass microsphere therapy administered through the hepatic artery at index procedure.
Hyogo College of Medicine Hospital
Nishinomiya, Hyōgo, Japan
NOT_YET_RECRUITINGKanazawa University Hospital
Kanazawa, Ishikawa-ken, Japan
RECRUITINGKindai University Hospital
Sayama, Osaka, Japan
NOT_YET_RECRUITINGRate 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.
Time frame: 3-months post index procedure
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
Time frame: 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
Time frame: 6-months post index procedure
Best response using localized RECIST 1.1 and localized mRECIST criteria.
Time frame: Through 6-months post index procedure
Proportion of patient receiving concomitant and post BSJ019T treatment, including subsequent local and systemic anticancer treatment, surgery, intervention and best supportive care.
Time frame: 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.
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))
Time frame: Through 6-months post index procedure
Technical success in delivering the Y-90 microspheres
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.
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National Cancer Center Hospital
Chuo Ku, Tokyo, Japan
NOT_YET_RECRUITINGTime frame: During the index procedure
Health-related quality of life (HRQoL) using EQ-5D questionnaires at regular intervals
Time frame: Baseline, 1-, 3- and 6-months post treatment
Health-related quality of life (HRQoL) using FACT-G questionnaires at regular intervals
Time frame: Baseline, 1-, 3- and 6-months post treatment
Overall survival
Time frame: Through study completion, an average of 1 year