What side effects are associated with this type of intervention?

Common treatments for liver cancer, such as Selective Internal Radiation Therapy (SIRT) using SIR-Spheres Y-90 resin microspheres, can have several side effects. These include fatigue, abdominal pain, nausea, and vomiting. There is also a risk of liver toxicity, which can manifest as elevated liver enzymes and bilirubin levels. Other potential side effects include gastroduodenal ulcers and, in rare cases, radiation-induced liver disease. Similar treatments like Transarterial Chemoembolization (TACE) can cause post-embolization syndrome, characterized by fever, pain, and nausea, while External Beam Radiation Therapy (EBRT) may lead to skin irritation and gastrointestinal symptoms.

What prior FDA approvals exist?

The FDA has approved several treatments for liver cancer, including locoregional therapies like Selective Internal Radiation Therapy (SIRT) using yttrium-90 (Y-90) resin microspheres, known as SIR-Spheres. These microspheres deliver targeted radiation directly to the tumor, minimizing damage to surrounding healthy tissue. Other FDA-approved treatments for liver cancer include systemic therapies like sorafenib (Nexavar), a tyrosine kinase inhibitor, and lenvatinib (Lenvima), which are used for advanced hepatocellular carcinoma. These treatments aim to control tumor growth and improve survival rates in patients with unresectable liver cancer.

What other types of research exist?

Promising alternatives to SIR-Spheres Y-90 resin microspheres for liver cancer patients 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 has demonstrated safety and efficacy in multiple studies. 3) Stereotactic Body Radiotherapy (SBRT), which offers precise targeting of tumors with minimal damage to surrounding tissues. 4) Combination therapies such as Sorafenib plus hepatic arterial infusion chemotherapy, which have shown improved outcomes in advanced cases.

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Radiation

SIRT with Y-90 Microspheres for Liver Cancer (DOORwaY90 Trial)

N/A

Waitlist Available

Led By Armeen Mahvash, M.D.

Research Sponsored by Sirtex Medical

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group (ECOG) performance score of ≤1 at baseline

Age 18 or older at the time of consent

Must not have

Incompetent biliary duct system, prior biliary intervention or a compromised Ampulla of Vater

History of other cancer with current active treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post-procedure follow-up: 1, 2, 4, 6, 9, 12, 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests tiny radioactive beads to treat liver cancer in patients who can't have surgery. The beads are injected into the liver and release radiation directly to the tumor to help control its growth. These beads have been used to deliver high doses of radiation directly to the tumor.

Who is the study for?

This trial is for adults with unresectable hepatocellular carcinoma (HCC) who have not had prior cancer treatments and whose liver function is relatively preserved. They should have a life expectancy of more than 3 months, measurable tumors by imaging, and be able to consent. Exclusions include those with extrahepatic disease, history of severe allergies or other cancers under active treatment, certain blood disorders, drug/alcohol dependency, or conditions affecting study participation.

What is being tested?

The trial tests SIR-Spheres Y-90 resin microspheres as a first-line treatment for local control of HCC in patients at various stages (BCLC A-C). These tiny beads deliver targeted radiation directly to the liver tumors. The goal is to assess safety and effectiveness compared to standard treatments.

What are the potential side effects?

Potential side effects may include abdominal pain or discomfort post-procedure, nausea, fatigue due to radiation exposure; there's also a risk of inflammation in the liver or nearby organs from radiation damage. Rarely complications like ulcers or gastrointestinal bleeding can occur if microspheres inadvertently reach other areas.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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I am 18 years old or older.

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My liver cancer diagnosis was confirmed by specific imaging or tissue analysis.

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I had liver surgery with clear margins, no tiny vessel invasion, and no new or returning cancer for 6 months.

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I had a small tumor treated without surgery and it hasn't come back in 6 months.

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My kidney function is good.

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My liver cancer is at a stage where it can be treated and the largest tumor is 8 cm or smaller.

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I am mentally capable and willing to sign the consent form.

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My liver function is slightly impaired.

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My doctor expects me to live more than 3 months without treatment.

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My tumors can be measured using a CT scan or MRI.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have issues with my bile ducts or have had procedures on them.

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I am currently being treated for another type of cancer.

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I have no detectable abnormal flow of a tracer outside my liver after certain procedures.

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My treatment plan includes a high dose of radiation to the lungs.

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I am scheduled for ongoing cancer treatment during the study.

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I need oxygen therapy regularly due to a lung condition.

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I have had signs of high blood pressure in the liver veins or bleeding from these veins in the last 6 months.

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I am not planning any liver cancer treatments other than the study treatment.

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I have a blood clot in the vein to my liver.

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I am not pregnant, breastfeeding, and if premenopausal, I am willing to use contraception for 1 year. If male, I agree to use contraception for 30 days post-procedure.

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I have received treatments like immunotherapy or radiotherapy for liver cancer before.

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I cannot undergo angiography or selective visceral catheterization due to health risks.

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Less than a third of my liver is free of disease and won't be treated with SIR-Spheres.

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My cancer has spread outside of my liver.

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I have a history of blood clotting disorders.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post-procedure follow-up: 1, 2, 4, 6, 9, 12, 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post-procedure follow-up: 1, 2, 4, 6, 9, 12, 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and post-procedure follow-up: 1, 2, 4, 6, 9, 12, 24 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)

Overall Response Rate (ORR)

Secondary study objectives

Grade ≥ 3 toxicity (CTCAE v5.0)

Incidence of liver resection

Incidence of liver transplant

+2 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: Open-label Single ArmExperimental Treatment1 Intervention

Open-label single arm study evaluating treatment with hepatic arterial injection of SIR-Spheres.

0 / 26Eligibility criteria met

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

SIR-Spheres Y-90 resin microspheres work by delivering targeted radiation directly to liver tumors through the hepatic artery, using yttrium-90, a beta-emitting isotope. This localized approach minimizes damage to surrounding healthy tissue. Similarly, transarterial chemoembolization (TACE) combines chemotherapy with embolic agents to block blood flow to the tumor, enhancing drug retention and tumor cell death. External beam radiation therapy (EBRT) uses high-energy beams to destroy cancer cells, but it is less targeted compared to SIRT. Understanding these mechanisms helps liver cancer patients and their doctors choose treatments that maximize tumor control while minimizing side effects, improving overall outcomes and quality of life.