Radioembolization with EYE90 Microspheres for Liver Cancer

Recruiting at 20 trial locations

Overseen By ABK Biomedical

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: ABK Biomedical

Disqualifiers: Low platelets, High INR, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing Eye90 microspheres®, tiny beads with radioactive material, on patients with liver cancer that can't be removed by surgery. The beads deliver radiation directly to the tumor to kill cancer cells. Yttrium-90 microspheres have been increasingly used for treating liver cancers that cannot be surgically removed by delivering high doses of radiation directly to tumors.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

How is the EYE90 Microspheres treatment different from other liver cancer treatments?

The EYE90 Microspheres treatment is unique because it involves injecting tiny radioactive beads directly into the liver's blood supply, delivering targeted radiation to liver tumors. This method, known as radioembolization, allows for a focused treatment of liver cancer, especially when surgery is not an option, and is different from traditional systemic therapies that affect the whole body. ^{1 2 3 4 5}

What data supports the effectiveness of the EYE90 Microspheres treatment for liver cancer?

Research shows that Yttrium-90 microspheres, similar to EYE90 Microspheres, are effective in treating liver cancer by extending the time before the disease progresses and providing a survival benefit for patients with liver metastases from colorectal cancer. ^{1 6 7 8 9}

Who Is on the Research Team?

Andrew Kennedy, MD

Principal Investigator

Director, Radiation Oncology Research at Sarah Cannon

Ammar Sarwar, MD

Principal Investigator

Director of Radiation Oncology Research, Beth Israel Deaconess Medical Center

Aravind Arepally, MD

Principal Investigator

ABK Biomedical, Inc

Are You a Good Fit for This Trial?

This trial is for adults with unresectable Hepatocellular Carcinoma (HCC) who have a single liver tumor ≤ 8 cm or multiple tumors with a combined size of ≤ 12 cm. Participants must have at least one measurable lesion, no extra hepatic disease, and a life expectancy of over 6 months. They cannot join if they have severe kidney issues, blood disorders, compromised biliary systems, or are at risk for high radiation exposure to the lungs.

Inclusion Criteria

At least one lesion must be identified as a target lesion as defined by mRECIST

I have up to 3 cancer spots, with one being at least 2 cm big.

Hypervascular on CBCT, CT, or MRI

Exclusion Criteria

Platelet count <50,000/microliter or prothrombin (PT) activity > 50% normal

Bilirubin ≥ 2.0 mg/dL

AST > 5x upper limit

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive radioembolization with Eye90 Microspheres for the treatment of unresectable Hepatocellular Carcinoma

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• EYE90 Microspheres Treatment

Trial Overview The study tests Eye90 microspheres®, which deliver targeted radiation directly to liver tumors using yttrium-90 (Y-90). The goal is to treat all lesions in one session and evaluate the effectiveness and safety of this local brachytherapy approach in patients with HCC.

How Is the Trial Designed?

Group I: EYE90 Microspheres Treatment Experimental Treatment 1 Intervention

Radioembolization with Eye90 Microspheres

EYE90 Microspheres Treatment is already approved in United States for the following indications:

Approved in United States as Eye90 Microspheres for:

• Hepatocellular Carcinoma (HCC)

Who Is Running the Clinical Trial?

ABK Biomedical

Lead Sponsor

Trials

2

Recruited

130+

Published Research Related to This Trial

Yttrium-90 microspheres are being increasingly utilized for treating both primary and secondary liver tumors, indicating their growing acceptance in clinical practice.

The article discusses over 900 radioembolization procedures conducted over 5 years, highlighting the need for further dialogue in the interventional oncology community regarding the complexities and controversies of this treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radioembolization with 90yttrium microspheres: a state-of-the-art brachytherapy treatment for primary and secondary liver malignancies. Part 2: special topics. Salem, R., Thurston, KG.[2022]

In a study of 46 patients with inoperable hepatocellular carcinoma, those who received transarterial radioembolization with yttrium-90 microspheres had significantly longer survival compared to those who did not receive the treatment, especially in patients with specific tumor characteristics.

While radioembolization showed promise in prolonging survival, it also led to side effects such as grade 2 irradiation-induced gastritis in 10% of patients and radioembolization-induced liver disease in 13%, indicating the need for careful monitoring and further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survival benefit of radioembolization for inoperable hepatocellular carcinoma using yttrium-90 microspheres. Kwok, PC., Leung, KC., Cheung, MT., et al.[2014]

In a study of 12 patients who underwent selective internal radiation therapy (SIRT) with Y90 microspheres, liver resection was found to be a viable option for some patients with unresectable tumors, potentially extending their overall survival.

Despite the high rates of perioperative morbidity (42%) and a 42% readmission rate, the procedure shows promise for selected patients, indicating that Y90 treatment can lead to favorable surgical outcomes in the context of multimodal therapy for liver cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liver Resection After Selective Internal Radiation Therapy with Yttrium-90 is Safe and Feasible: A Bi-institutional Analysis. Wright, GP., Marsh, JW., Varma, MK., et al.[2018]

Yttrium-90 (Y90) microsphere treatment for patients with liver-dominant colorectal metastases showed a tumor response rate of 40.3% and a median overall survival of 14.5 months after treatment, indicating its efficacy in managing this condition.

The treatment was generally safe, with common side effects including fatigue (61%) and nausea (21%), and it was particularly beneficial for asymptomatic patients with good liver function, who had a median survival of 42.8 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radioembolization of colorectal hepatic metastases using yttrium-90 microspheres. Mulcahy, MF., Lewandowski, RJ., Ibrahim, SM., et al.[2022]

Yttrium-90 (Y-90) microsphere therapy, also known as selective internal radiation therapy (SIRT), has been shown to effectively extend the time to disease progression and improve survival in patients with liver metastases from colorectal cancer (CRC).

This review compiles data from various clinical trials and studies, highlighting the methodology, outcomes, and side effects of Y-90 therapy, indicating its growing role as a treatment option for patients who are not candidates for surgery or have failed systemic chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Yttrium-90 radioembolization of hepatic metastases from colorectal cancer. Raval, M., Bande, D., Pillai, AK., et al.[2021]

Yttrium-90 (Y90) radioembolization therapy using TheraSphere® has been deemed safe and effective for treating hepatocellular carcinoma (HCC), even in patients with portal vein thrombosis, according to the Radioembolization Brachytherapy Oncology Consortium.

Despite promising initial results, there are currently no randomized clinical trials demonstrating a survival benefit for TheraSphere®, indicating the need for further research before it can be fully recommended as a treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radioembolization for hepatocellular carcinoma using TheraSphere®. Ali, SM.[2021]

Microsphere-based radioembolization is a promising new treatment for diffuse or multifocal liver tumors, allowing targeted therapy directly to the liver via the hepatic artery, which is a significant advancement over traditional systemic therapies.

The standard method for this treatment involves using yttrium-90 glass or resin microspheres, which have shown effective therapeutic results in interventional oncology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Selective internal radiotherapy (SIRT) for hepatocellular carcinoma]. Antoch, G., Mueller, SP., Hamami, M., et al.[2010]

In a pilot study involving 5 patients with liver tumors, PET/CT imaging successfully localized 90Y glass microspheres after radioembolization, demonstrating its effectiveness in confirming microsphere deposition.

No adverse events related to the treatment were reported, indicating that radioembolization with 90Y microspheres is a safe procedure for patients with hepatocellular carcinoma and liver metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internal pair production of 90Y permits hepatic localization of microspheres using routine PET: proof of concept. Gates, VL., Esmail, AA., Marshall, K., et al.[2022]

In a study of 4 patients with hepatocellular carcinoma and macrovascular invasion, Yttrium-90 microspheres radioembolization (Y90-RE) led to complete regression of thrombosis, allowing them to qualify for liver transplantation.

The procedure was safe, with no deaths reported during or after Y90-RE, and resulted in a disease-free survival of 39.1 months, suggesting that Y90-RE can be an effective downstaging treatment for patients with advanced liver cancer before transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hepatocellular carcinoma with macrovascular invasion treated with yttrium-90 radioembolization prior to transplantation. Levi Sandri, GB., Ettorre, GM., Colasanti, M., et al.[2020]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Radioembolization with 90yttrium microspheres: a state-of-the-art brachytherapy treatment for primary and secondary liver malignancies. Part 2: special topics. [2022]

2. Australia pubmed.ncbi.nlm.nih.gov

Survival benefit of radioembolization for inoperable hepatocellular carcinoma using yttrium-90 microspheres. [2014]

3. United States pubmed.ncbi.nlm.nih.gov

Liver Resection After Selective Internal Radiation Therapy with Yttrium-90 is Safe and Feasible: A Bi-institutional Analysis. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Radioembolization of colorectal hepatic metastases using yttrium-90 microspheres. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Yttrium-90 radioembolization of hepatic metastases from colorectal cancer. [2021]

6. India pubmed.ncbi.nlm.nih.gov

Radioembolization for hepatocellular carcinoma using TheraSphere®. [2021]

7. Germany pubmed.ncbi.nlm.nih.gov

[Selective internal radiotherapy (SIRT) for hepatocellular carcinoma]. [2010]

8. United States pubmed.ncbi.nlm.nih.gov

Internal pair production of 90Y permits hepatic localization of microspheres using routine PET: proof of concept. [2022]

9. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

Hepatocellular carcinoma with macrovascular invasion treated with yttrium-90 radioembolization prior to transplantation. [2020]