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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

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 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

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.

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.

Find a Location

Who is running the clinical trial?

Sirtex MedicalLead Sponsor
29 Previous Clinical Trials
4,188 Total Patients Enrolled
1 Trials studying Liver Cancer
36 Patients Enrolled for Liver Cancer
Bright Research PartnersIndustry Sponsor
17 Previous Clinical Trials
2,554 Total Patients Enrolled
Armeen Mahvash, M.D.Principal InvestigatorM.D. Anderson Cancer Center

Media Library

Resin microspheres containing yttrium-90 (Y-90) (Radiation) Clinical Trial Eligibility Overview. Trial Name: NCT04736121 — N/A
Liver Cancer Research Study Groups: Open-label Single Arm
Liver Cancer Clinical Trial 2023: Resin microspheres containing yttrium-90 (Y-90) Highlights & Side Effects. Trial Name: NCT04736121 — N/A
Resin microspheres containing yttrium-90 (Y-90) (Radiation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04736121 — N/A
~21 spots leftby Oct 2025