Status:
ACTIVE_NOT_RECRUITING
Selective Internal Radiation Therapy (SIRT) Using SIR-Spheres® Y-90 Resin Microspheres on DoR & ORR in Unresectable Hepatocellular Carcinoma Patients
Lead Sponsor:
Sirtex Medical
Collaborating Sponsors:
Bright Research Partners
Conditions:
Unresectable Hepatocellular Carcinoma
BCLC Stage A Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 Barc...
Detailed Description
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 15...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04736121
Start Date
May 28 2021
End Date
December 1 2026
Last Update
February 5 2025
Active Locations (22)
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1
University of California Los Angeles - Ronald Reagan Medical Center
Los Angeles, California, United States, 90095
2
Providence St. Joseph Hospital
Orange, California, United States, 92868
3
University of California Irvine
Orange, California, United States, 92868
4
Miami Cardiac and Vascular Institute at Baptist Hospital
Miami, Florida, United States, 33176