Clinical trial NCT04926376: Safety and Effectiveness of Eye90 Microspheres™ in the Treatment of Unresectable Hepatocellular Carcinoma (HCC) and Metastatic Colorectal Cancer (mCRC)
Official title: Investigation of Safety and Effectiveness of Eye90 Microspheres™ in the Treatment of Unresectable Hepatocellular Carcinoma (HCC) and Metastatic Colorectal Cancer (mCRC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatocellular Carcinoma Non-resectable
Metastatic Colorectal Cancer
Liver Cancer
Keywords: Hepatocellular Carcinoma
Metastatic Colorectal Cancer
Liver Neoplasms
Liver Diseases
Internal radiation brachytherapy
Radioembolization
Y90
Yttrium-90
Eye90 microspheres
Lead sponsor: ABK Biomedical
Sponsor class: INDUSTRY
First posted: 2021-06-15
Enrollment: 8
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
Intervention model description: Open Label
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety of treatment with Eye90 microspheres in patients with unresectable Hepatocellular Carcinoma (HCC) and metastatic Colorectal Cancer (mCRC). Both cause tumors, known as malignant hyper-vascular hepatic neoplasia, that have an abnormally large number of blood vessels attached to them. Eye90 is internal radiation brachytherapy for treatment of malignant hyper-vascular hepatic neoplasia that uses microspheres, tiny glass beads smaller in diameter than a human hair, to provide radiation. The microspheres contain Yttrium-90 (Y90) as the radiation source, which are used to to kill cancer cells and shrink tumors. The microspheres are also radiopaque, which means that they can be seen during imaging procedures. The visibility of the microspheres allows the study doctor to confirm the microspheres have been delivered in the tumor; this may help to improve the outcome of treatment.


Eligibility criteria: Inclusion Criteria:

* Measurable disease defined as at least one unidimensional measurable lesion by computed tomography (CT) or magnetic resonance imaging (MRI).
* Must have at least one lesion \> 2 cm within the target perfused volume.
* At least one lesion must meet the definition of target lesion as defined by RECIST 1.1 or mRECIST.
* Total linear length of all lesions must be ≤ 9 cm.
* Must have preservation of \>700cc of normal liver parenchyma outside of treated volume.
* Hypervascular lesions on CT scan with 99mTC MAA SPECT/CT T:N ratio 3:1 or higher and Hypervascular on CBCT.
* No prior locoregional therapies in the liver other than previous Drug Eluting Bead TACE and/or local HCC recurrence after thermal ablation. Last TACE and/or ablation treatment must be at least 3 months prior to informed consent. Prior Lumi or Lipiodol TACE is not allowed.
* Life expectancy of ≥ 6 months.
* ≥ 18 years old.

Exclusion Criteria:

* Hemoglobin ≤ 85 mg/L.
* Platelet count \< 50,000/microliter or prothrombin (PT) activity \> 50% normal
* INR \> 1.4 (if anticoagulated, reversal must be achieved prior to any angiographic procedures).
* ALT \> 2.5x upper limit
* AST \> 2.5x upper limit
* For HCC subjects, Bilirubin ≥ 2 mg/dL.
* For mCRC subjects, Bilirubin ≥ 1.2 mg/dL.
* eGFR ≤ 60 mL/min/1.73 m2.
* Portal vein thrombosis (PVT).
* Incompetent biliary duct system, prior biliary intervention, or a compromised Ampulla of Vater
* Estimated lung dose \> 30 Gy as calculated using the lung shunt % and partition model.

Primary outcomes:
measure: Incidence of toxicity
timeFrame: 6 months
measure: Incidence of TESAEs
timeFrame: 6 months
measure: Overall Response Rate (ORR) by RECIST 1.1
timeFrame: 6 months
measure: Overall Response Rate (ORR) by mRECIST
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Grafton
country: New Zealand
facility: Auckland District Health Board
Study officials:
affiliation: ABK Biomedical
name: Chief Medical Officer
role: STUDY_DIRECTOR
References: