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

Running, not enrolling · Not applicable

Conditions studied: Unresectable Hepatocellular Carcinoma, BCLC Stage A Hepatocellular Carcinoma, BCLC Stage B Hepatocellular Carcinoma, BCLC Stage C Hepatocellular Carcinoma

In brief

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).

Key facts

Study ID: NCT04736121
Run by: Sirtex Medical
People needed: 100
Starts: 2021-05-28
Expected to finish: 2026-09-01
Last updated by the study team: 2026-02-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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
Patients with portal vein thrombosis
Patients with extrahepatic disease
Patients with contraindications to angiography and selective visceral catheterization
Evidence of extrahepatic collateral supply to the tumor
Evidence of potential delivery of mean radiation dose > 30 Gy to the lungs (single treatment)
Evidence of any detectable 99m Tc-macroaggregated albumin (99m Tc-MAA) flow outside of the liver in the abdomen, after application of established angiographic techniques to stop or mitigate such flow (e.g., placing catheter distal to gastric vessels or coiling)
Evidence that < 33% of the total liver volume is disease-free and will be spared SIR-Spheres treatment
Prior liver resection and/or liver transplant, with exception for patients with prior resection who meet inclusion criterion 6a
Female patients who are pregnant, breastfeeding, or premenopausal and unwilling to use an effective method of contraception through the 1-year follow-up; males unwilling to use effective method of contraception for 30 days post-procedure
Medical history of clotting disorders
Underlying pulmonary disease requiring chronic oxygen therapy
Evidence of portal hypertension with ascites as seen on cross-sectional imaging or any history of prior variceal bleeding within 6 months prior to screening
Concurrently enrolled in another study unless it is an observational, noninterventional study
Active infection (hepatitis B (HBV) infection with ongoing HBV treatment and successfully treated hepatitis C infection are allowed)
History of other cancer with current active treatment
Patients with drug or alcohol dependency (within 6 months prior to study entry) in the opinion of the investigator
History of severe allergy or intolerance to contrast agents, narcotics, or sedatives
Any condition that, in the opinion of the investigator, would interfere with safe delivery of the study treatment or with the interpretation of study results

Where it is running

University of California Los Angeles - Ronald Reagan Medical Center — Los Angeles, California, United States
Providence St. Joseph Hospital — Orange, California, United States
University of California Irvine — Orange, California, United States
Miami Cardiac and Vascular Institute at Baptist Hospital — Miami, Florida, United States
Sarasota Memorial Health Care System — Sarasota, Florida, United States
Emory University Hospital Midtown — Atlanta, Georgia, United States
University of Kansas Medical Center — Kansas City, Kansas, United States
Massachusetts General Hospital — Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
Columbia University CUIMC/NYPH — New York, New York, United States
University of North Carolina - Chapel Hill Medical Center — Chapel Hill, North Carolina, United States
Wake Forest Baptist Health — Winston-Salem, North Carolina, United States
University of Cincinnati Cancer Center CTO — Cincinnati, Ohio, United States
The Cleveland Clinic Foundation — Cleveland, Ohio, United States
Hospital of the University Pennsylvania — Philadelphia, Pennsylvania, United States
Allegheny-Singer Research Institute — Pittsburgh, Pennsylvania, United States
Rhode Island Hospital — Providence, Rhode Island, United States
Clinical Research Institute and Methodist Hospital — Dallas, Texas, United States
University of Texas Health Science Center at Houston — Houston, Texas, United States
UT MD Anderson Cancer Center — Houston, Texas, United States
The University of Vermont Medical Center — Burlington, Vermont, United States
Inland Imaging — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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