Selective Internal Radiation Therapy (SIRT) Using SIR-Spheres® Y-90 Resin Microspheres on DoR & ORR in Unresectable Hepatocellular Carcinoma Patients
Liver Cancer / Hepatoblastoma
18 Years and older, Male and Female
STX2001 (primary)
NCI-2021-13336
Summary
The objective of this pivotal study is to evaluate the safety and effectiveness of SIRT using
SIR-Spheres Y-90 resin microspheres as first-line treatment for local control of HCC in
patients with Barcelona Clinic Liver Cancer (BCLC) stage A, B1, B2, and C.
SIR-Spheres consist of biocompatible resin microspheres containing yttrium-90 (Y-90), with a
size between 20 and 60 microns in diameter. Y-90 is a high-energy pure beta-emitting isotope
with no primary gamma emission.
SIR-Spheres are indicated for the local tumor control of unresectable hepatocellular
carcinoma (HCC) in patients with Barcelona Clinic Liver Cancer (BCLC) stage A, B1 and B2,
maximal single lesion size of 8 cm, no macrovascular invasion, well-compensated liver
function and good performance status. It is also indicated for the treatment of unresectable
metastatic liver tumors from primary colorectal cancer with adjuvant intra-hepatic artery
chemotherapy (IHAC) of Floxuridine (FUDR).
Objectives
The investigation is a pivotal, prospective, multicenter, open-label single arm study
evaluating treatment with hepatic arterial injection of SIR-Spheres.
Up to 100 subjects will be treated (up to 150 consented) at up to 30 clinical sites in the
United States.
The population for this study includes patients diagnosed with HCC BCLC stage A, B1, B2, and
C with maximal single lesion size of = 8cm and who are not considered suitable for treatment
by resection or eligible for ablation at time of study entry.
Eligibility
- Willing, able, and mentally competent to provide written informed consent
- Age 18 or older at the time of consent
- All tumors must be measurable by CT or MRI according to localized mRECIST
- Life expectancy = 6 months (to allow for adequate completion of study procedures and collection of data)
- Diagnosis of HCC with Liver Imaging Reporting and Data System (LIRADS) 4 or 5 or by histology
- Treatment-naïve patients or patients who have developed a new lesion following one of these prior locoregional treatments:
- Liver resection with negative pathologic margins, no microvascular invasion, and no recurrence at resection margins for at least 6 months post-treatment and no new lesions within 6 months of liver resection
- Ablation of a single =3cm lesion with no recurrence of the treated lesion for at least 6 months post-treatment
- BCLC stage A, B1, B2, and C with maximal single tumor size of =8 cm and sum of the maximal tumor dimensions of =12 cm with the entire tumor burden expected to be treatable within the perfused volume
- At least one lesion =1 cm in diameter (long axis) measured according to mRECIST criteria by CT or MRI
- Child-Pugh score of A5 or A6 at baseline
- Eastern Cooperative Oncology Group (ECOG) performance score of =1 at baseline
- Adequate blood count, liver enzymes, and renal function at baseline
- Platelet count >50,000/microliter (patients may not receive a platelet transfusion or growth factors to increase the platelet count so that the patient may be eligible for the study)
- White Blood Cell (WBC) = 3 x 10^9/L
- Hemoglobin > 8.5 g/dL
- Aspartate transaminase (AST) & Alanine transaminase (ALT) < 5 x upper limit normal
- Bilirubin = 2.0 mg/dL
- Albumin > 3.0 g/dL
- International normalized ratio (INR) = 2.0
- Glomerular filtration rate (GFR) > 50
- Negative serum pregnancy test at baseline
- Life expectancy of > 3 months without any active treatment
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