A TheraSphere® Advanced Dosimetry Retrospective Global Study in HCC

ID#: NCT03295006

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Recruitment Status: Recruiting

Start Date: October 31, 2016

End Date: November 30, 2019

Contact Information:
Frances Harrison

This retrospective, multinational, single-arm study will be conducted in at least 8 sites. An interim analysis will be conducted with data from 100 patients with up to 10 well defined HCC tumor(s) and with at least one tumor ≥3 cm. Normal tissue absorbed dose using pre-procedural 99mTc MAA SPECT or SPECT/CT imaging will be measured to allow the mean absorbed normal tissue dose corresponding to a ≤15% probability of CTCAE grade 3 or higher hyperbilirubinemia (in the absence of disease progression) to be calculated. Total bilirubin will be recorded and graded according to CTCAE version 4.02. All dose-related SAEs at 3 months follow-up will be followed until resolution, death or lost-to-follow-up. AEs related to disease progression will not be considered related to TheraSphere.


Inclusion Criteria:

- Up to 10 well defined unilobar/bilobar HCC tumor(s) per lobe with at least one tumor ≥3 cm ± PVT

- Liver dominant disease (limited extra-hepatic metastases in the lung and/or lymph nodes are permitted (up to 5 lesions in the lung, with each individual lesion ≤2cm; any number of lymph node lesions with each individual lesion ≤2 cm).

- Child Pugh stage A or B7.

- BCLC A, B or C.

- Must be male or female, 18 years of age or older.

- Bilirubin ≤2 mg/dL.

- Tumor replacement <50% of total liver volume assessed by diagnostic imaging consisting of multi-phase contrast enhanced CT or contrast enhanced MRI.

- Diagnostic imaging consisting of multi-phase contrast enhanced CT or contrast enhanced MRI within 3 months prior to TheraSphere® administration.

- Infusion of 99mTc-MAA in a single arterial location sufficient to cover up to 10 well-defined tumors per lobe ≤ 6 weeks prior to TheraSphere® administration.

- Patients must have received TheraSphere® in a single treatment setting in one or more arterial locations sufficient to cover up to 10 well-defined tumors based on angiography. Subsequent TheraSphere® treatment to the second lobe may occur at least 4 weeks following the initial TheraSphere® treatment.

- For patients receiving a second TheraSphere® treatment bilirubin levels must have been recorded prior to the second treatment

- Patients must have had clinical evaluation (assessment of liver specific AEs) and laboratory evaluation (at least a serum bilirubin level) at baseline.

- Tumor(s), ≥3 cm, measurable by mRECIST and RECIST 1.1 at baseline

Exclusion Criteria:

- Prior external beam radiation treatment to the liver.

- Prior loco-regional liver directed therapy (cTACE, DEB-TACE and SIR-Spheres).

- Prior liver transplantation.

- Whole liver TheraSphere® treatment following prior liver resection.

- TheraSphere administration to ≤2 segments (e.g., radiation segmentectomy).

- Additional active therapy (TACE and treatment with SIR-Spheres) between first TheraSphere treatment and 3 month (90 days) imaging.

- Hepatic vein invasion.

- Diagnosis of disease progression at peri-procedural imaging as compared to the baseline imaging (physician's discretion).