Clinical trial NCT05953337: Radioembolization Trial Utilizing Eye90 Microspheres™ for the Treatment of Hepatocellular Carcinoma (HCC)
Official title: Radioembolization Oncology Trial Utilizing Transarterial Eye90 (ROUTE 90) for the Treatment of Hepatocellular Carcinoma (HCC)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hepatocellular Carcinoma
Hepatocellular Carcinoma Non-resectable
Liver Cancer
Keywords: Hepatocellular Carcinoma
Liver Cancer
Liver Diseases
Internal radiation brachytherapy
Radioembolization
Y90
Yttrium-90
Eye90 microspheres
Lead sponsor: ABK Biomedical
Sponsor class: INDUSTRY
First posted: 2023-07-20
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, multi-center, open-label study to evaluate the effectiveness and safety of Eye90 microspheres® in the treatment of subjects with unresectable Hepatocellular Carcinoma (HCC). Eye90 microspheres is a medical device containing yttrium-90 (Y-90), a radioactive material, and provides local radiation brachytherapy for the treatment of liver tumors.


Eligibility criteria: Inclusion Criteria:

* Must have a confirmed diagnosis of HCC by imaging confirmation with Liver Imaging Reporting and Data System (LIRADS) category 5 or confirmation of HCC via biopsy.
* No extra hepatic disease.
* Up to 3 lesions with at least one lesion ≥ 2 cm in diameter (long axis) measurable by computed tomography (CT), CBCT, or MRI. At least one lesion must be identified as a target lesion as defined by mRECIST.
* Maximal single lesion 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.
* Intent to treat all lesions within a single session.
* Hypervascular on CBCT, CT, or MRI.
* Evidence that \> 33% of the total liver volume is disease-free and will be spared Eye90 treatment.
* Life expectancy of ≥ 6 months.
* ≥ 18 years old at the time of informed consent

Exclusion Criteria:

* Platelet count \<50,000/microliter or prothrombin (PT) activity \> 50% normal.
* Hemoglobin ≤ 8.5 g/dL (subjects that are non-responders to transfusion or medical management must be excluded).
* INR \> 1.7 (if anticoagulated, reversal must be achieved prior to any angiographic procedures).
* ALT \> 5x upper limit.
* AST \> 5x upper limit.
* Bilirubin ≥ 2.0 mg/dL.
* eGFR ≤ 50 mL/min/BSA.
* Macrovascular invasion.
* Incompetent biliary duct system, prior biliary intervention, or a compromised Ampulla of Vater.
* Estimated lung dose \> 30 Gy as calculated using the lung shunt fraction and partition model.

Primary outcomes:
measure: Overall response rate (ORR)
timeFrame: 6 months
measure: Duration of response (DoR)
timeFrame: 6 months
measure: Incidence of adverse events (AEs)
timeFrame: 12 months
measure: Incidence of serious adverse events (SAEs)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: The University of Arizona Cancer Center
state: Arizona
city: Orange
country: United States
facility: University of California - Irvine
state: California
city: Altamonte Springs
country: United States
facility: AdventHealth Radiation Oncology at Altamonte Springs
state: Florida
city: Miami
country: United States
facility: Miami Cardiac and Vascular Institute at Baptist Hospital Miami
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital Midtown
state: Georgia
city: Atlanta
country: United States
facility: Piedmont Hospital
state: Georgia
city: Chicago
country: United States
facility: University of Illinois Hospital and Health Sciences System
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa Health Care
state: Iowa
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Boston
country: United States
facility: Beth Israel Deaconess
state: Massachusetts
city: Columbia
country: United States
facility: University of Missouri - Ellis Fischel Cancer Center
state: Missouri
city: St. Louis
country: United States
facility: SSM Health Saint Louis University
state: Missouri
city: New York
country: United States
facility: Weill Cornell Medicine-New York Presbyterian Hospital
state: New York
city: Charlotte
country: United States
facility: Charlotte Radiology
state: North Carolina
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Nashville
country: United States
facility: HCA Healthcare Research Institute (Sarah Cannon)
state: Tennessee
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Spokane
country: United States
facility: Inland Imaging
state: Washington
city: Milwaukee
country: United States
facility: Froedtert Hospital/Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Director, Radiation Oncology Research at Sarah Cannon
name: Andrew Kennedy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Director of Radiation Oncology Research, Beth Israel Deaconess Medical Center
name: Ammar Sarwar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: ABK Biomedical, Inc
name: Aravind Arepally, MD
role: STUDY_DIRECTOR
References: