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New treatment option for Liver Neoplasms
Official title TheraSphere Japan Pre-Market Study
ClinicalTrials.gov ID: NCT07377487
What this study is testing
- What it's testing
- To investigate the safety and effectiveness of BSJ019T in Japanese patients with primary or secondary liver who are not candidate for standard treatment.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- [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)
You likely can't join if
- [Exclusion Criteria based on the clinical 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.
- Contraindications to angiography and selective visceral catheterization
- Received any prior external beam radiation treatment to the liver
- Received any prior yttrium-90 microsphere treatment to the liver
See the full eligibility 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 \ 50% prothrombin activity [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 Criteria based on the clinical 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.
- Contraindications to angiography and selective visceral catheterization
- 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)
- Plan to start systemic anticancer treatment in the next 3 month after the index procedure.
- 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.
- Evidence of pulmonary insufficiency or clinically evident chronic obstructive pulmonary disease
- 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)
- Previous liver function decompensation within the last 6 months (ascites, encephalopathy, jaundice)
- Patient with infiltrative disease presentation (not suitable for repeated measurement)
- Patients who are pregnant or breast-feeding and does not want to stop.
- 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 treatment clinical studies
- Any condition where the Investigator feels the patient would not be able to participate/finish the study
- Previous gastrointestinal bleeding related to portal hypertension within the last 3 months (preventive treatment is acceptable) [Exclusion Criteria based on the imaging evaluation]
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Nishinomiya, Hyōgo, Japan
- Kanazawa, Ishikawa-ken, Japan
- Sayama, Osaka, Japan
- Chuo Ku, Tokyo, Japan
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nishinomiya, Hyōgo, Japan; Kanazawa, Ishikawa-ken, Japan; Sayama, Osaka, Japan; Chuo Ku, Tokyo, Japan. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.