Selective Internal Radiation Therapy (SIRT) Using SIR-Spheres® Y-90 Resin Microspheres on DoR & ORR in Unresectable Hepatocellular Carcinoma Patients

Active:	Yes
Cancer Type:	Liver Cancer / Hepatoblastoma	NCT ID:	NCT04736121
Trial Phases:		Protocol IDs:	STX2001 (primary) NCI-2021-13336
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Sirtex Medical
NCI Full Details:	http://clinicaltrials.gov/show/NCT04736121

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.

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