HCC resection candidates with inadequate future liver remnant will be enrolled in this study. They will be treated with Y90 radioembolization to help grow the liver enough to undergo liver resection. There will be 2 Patient Groups. The first group of patients will be treated with Y90 dose and embolic load as per standard-of-care. The second group of patients will be treated with the optimal Y90 dose and embolic load found in Patient Group 1.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patients must have been diagnosed with HCC confirmed by histology or must meet one of the following American Association for the Study of Liver Diseases (AASLD) guidelines:
✓. Child-Pugh stage A
✓. Future Liver Remnant (FLR) of \< 40%
✓. ECOG Performance Status 0-1
✓. Bilirubin ≤ 3.0 mg/dl- Treatment may proceed if the Bilirubin is elevated if the tumor may be isolated from a vascular standpoint
✓. Creatinine ≤ 2.0 mg/dl
✓. ANC ≥ 1.5 K/uL
✓. Platelets \> 25 K/uL
Exclusion criteria
✕. Patient must not be pregnant
✕. For Patients in Group 2 only:
✕. Must not have any significant life-threatening extra-hepatic disease or life- threatening secondary malignancies, including patients who are on dialysis, have unresolved diarrhea, have serious unresolved infections including patients who are known to be HIV positive or have acute HBV or HCV
✕. Must not have any contraindications to angiography and selective visceral catheterization such as bleeding diathesis or coagulopathy that is not correctable by usual therapy of hemostatic agents (e.g. closure device)
What they're measuring
1
Patient Group 1: Y90 Glass Microspheres
Timeframe: 2 years
2
Patient Group 1: Sphere distribution
Timeframe: 2 years
3
Patient Group 2: Quantitative Imaging Radiologic Biomarkers
. Must not have any co-morbid disease or condition that would place the patient at undue risk and preclude safe use of TheraSphere treatment, in the Investigator's judgment
✕. History of severe peripheral allergy or intolerance to contrast agents, narcotics, sedatives or atropine that cannot be managed medically