What side effects are associated with this type of intervention?

Localized radiation therapies for liver cancer, such as Yttrium-90 (Y-90) radioembolization, can lead to several side effects. Commonly reported adverse effects include fatigue, abdominal pain, nausea, and elevated liver enzymes (alanine transaminase and bilirubin). There is also a risk of gastroduodenal ulcers. When combined with TACE, these treatments may increase the incidence of liver function deterioration and other gastrointestinal complications. Patients undergoing these therapies should be closely monitored for these potential side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for liver cancer, including localized radiation therapies. One notable example is TheraSphere®, which uses Yttrium-90 microspheres similar to Eye90 microspheres® for radioembolization. This treatment involves delivering high doses of radiation directly to the liver tumors while sparing surrounding healthy tissue. Other FDA-approved treatments for liver cancer include systemic therapies like sorafenib (Nexavar) and lenvatinib (Lenvima), which are tyrosine kinase inhibitors used for advanced hepatocellular carcinoma. These treatments highlight the range of therapeutic options available, from localized radiation to systemic drug therapies.

What other types of research exist?

Promising alternatives to Eye90 microspheres® for liver cancer treatment include: 1) Proton Beam Therapy, which has shown high local control rates and is particularly effective for large tumors or those with portal vein thrombus. 2) Transarterial Chemoembolization (TACE) with drug-eluting beads, which provides targeted chemotherapy delivery and has demonstrated efficacy in multiple studies. 3) Stereotactic Body Radiotherapy (SBRT), which offers precise radiation delivery with minimal damage to surrounding tissues. 4) Systemic therapies such as immunotherapy agents (e.g., pembrolizumab) and targeted therapies (e.g., lenvatinib combined with TACE), which have shown promising results in clinical trials.

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Brachytherapy

Radioembolization with EYE90 Microspheres for Liver Cancer

N/A

Recruiting

Led By Ammar Sarwar, MD

Research Sponsored by ABK Biomedical

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include localized pain, nausea, fatigue due to radiation exposure; there's also a risk of damage to surrounding healthy liver tissue or other nearby organs from the radioactive material.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Duration of response (DoR)

Incidence of adverse events (AEs)

Incidence of serious adverse events (SAEs)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: EYE90 Microspheres TreatmentExperimental Treatment1 Intervention

Radioembolization with Eye90 Microspheres

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Localized radiation therapy using Yttrium-90 (Y-90) microspheres, such as Eye90 microspheres®, involves injecting radioactive particles directly into the liver's blood supply. These particles emit radiation that targets and destroys cancer cells while sparing surrounding healthy tissue. This method is particularly beneficial for liver cancer patients as it provides a focused treatment with minimal systemic side effects. Other common treatments include transarterial chemoembolization (TACE), which combines chemotherapy with embolization to block the tumor's blood supply, and external beam radiation therapy (EBRT), which uses high-energy beams to target cancer cells. These treatments are crucial as they offer options for patients who are not candidates for surgery, aiming to control tumor growth and improve survival rates.