TheraSphere Japan Pre-Market Study
ConditionLiver Neoplasms
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBoston Scientific Corporation
About this trial
To investigate the safety and effectiveness of BSJ019T in Japanese patients with primary or secondary liver who are not candidate for standard treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
TheraSphere Y-90 glass microsphere
DeviceTheraSphere Y-90 glass microsphere therapy administered through the hepatic artery at index procedure.
Treatment groups
51 Participants
are divided into 1 treatment groupGroup A: TheraSphereExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
3-months post index procedureSecondary outcomes
1
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 procedure2
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 procedure3
Best response using localized RECIST 1.1 and localized mRECIST criteria.
Time frame
Through 6-months post index procedure4
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 procedureSponsors and contacts
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Source ClinicalTrials.gov