Selective Internal Radiation Therapy (SIRT) Using SIR-Spheres® Y-90 Resin Microspheres on DoR & O… (NCT04736121) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Selective Internal Radiation Therapy (SIRT) Using SIR-Spheres® Y-90 Resin Microspheres on DoR & ORR in Unresectable Hepatocellular Carcinoma Patients
United States100 participantsStarted 2021-05-28
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
. Patients eligible for ablation or resection for their malignancy, in the opinion of the investigator, at the time of screening
✕. Prior systemic anti-cancer therapy (including immunotherapy and/or targeted therapy), radiotherapy or use of other investigational agents for the treatment of HCC
✕. Intrahepatic arteriovenous shunting (arteriovenous shunting resulting from a biopsy is allowed but must be embolized during the pre-treatment mapping procedure)
✕. Incompetent biliary duct system, prior biliary intervention or a compromised Ampulla of Vater
✕. Planned localized cancer treatment to the liver, other than the study treatment, throughout the duration of the study.
✕. Planned systemic cancer treatment throughout the duration of the study