Y-90 TARE for Liver Cancer

(MARGIN Trial)

Overseen By Cameron Khakpour, BA

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Northwestern University

Disqualifiers: Extrahepatic metastases, Pregnancy, MRI contraindications, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find the best way to use a special type of radiation, Yttrium-90, to treat liver cancer that cannot be removed by surgery. Researchers seek to determine the optimal radiation dose needed to destroy cancerous parts of the liver. The trial includes two groups: one with patients who have liver scarring (cirrhosis) and another without. Suitable candidates have liver cancer affecting small areas that cannot be treated with surgery or standard methods. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people, offering participants a chance to contribute to significant advancements in cancer treatment.

Is there any evidence suggesting that Yttrium-90 Radiation Segmentectomy is likely to be safe for humans?

Research has shown that Yttrium-90 (Y90) Radiation Segmentectomy is a safe treatment for liver cancer. Studies have found that patients generally tolerate this treatment well. For those with early-stage liver cancer, Y90 has proven both effective and safe, resulting in high rates of tumor shrinkage.

One study compared different Y90 treatments and found similar safety levels across them. Another study demonstrated that Y90 radioembolization, which delivers radiation directly to the tumor, was safe for liver cancer patients.

Overall, Y90 treatment can improve outcomes and is considered a promising option for people with liver cancer. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for liver cancer?

Researchers are excited about Yttrium-90 Radiation Segmentectomy (Y90 RS) for liver cancer because it offers a targeted approach that minimizes damage to healthy tissue. Unlike traditional treatments such as surgery, chemotherapy, or external beam radiation, Y90 RS delivers radiation directly to the liver tumor via tiny beads infused with Yttrium-90, a radioactive isotope. This localized delivery allows higher doses of radiation to be used safely, potentially improving effectiveness while reducing side effects. Additionally, the precision of this treatment could benefit both cirrhotic and non-cirrhotic patients by tailoring doses to their specific needs, which is a promising step forward in personalized cancer therapy.

What evidence suggests that Yttrium-90 Radiation Segmentectomy might be an effective treatment for liver cancer?

Research has shown that Yttrium-90 Radiation Segmentectomy (Y90 RS) holds promise for treating liver cancer. This trial will divide participants into two groups: cirrhotic and non-cirrhotic patients. Studies have found that many patients experience a significant reduction or disappearance of their cancer, with few side effects. Specifically, one study found that about 77.3% of patients had their cancer shrink enough to meet specific treatment goals six months after therapy. Another analysis of over ten thousand patients demonstrated that this treatment improved overall survival and slowed cancer growth. Early results suggest Y90 RS can effectively manage liver tumors that cannot be removed by surgery. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for people with liver cancer (hepatocellular carcinoma) whose tumors cannot be removed by surgery or treated with standard ablation. Participants should have tumors in the liver that doctors think could benefit from targeted radiation.

Inclusion Criteria

I am 18 years old or older.

My tumor is 5 cm or smaller and affects no more than 2 liver segments.

My liver is working well or has only mild to moderate problems.

Exclusion Criteria

My cancer has spread outside my liver.

Pregnant or breastfeeding individuals

I am an adult who cannot give consent for myself.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Yttrium-90 transarterial radioembolization with dose escalation based on cirrhotic status

12 months

Multiple visits for imaging and dose adjustments

Follow-up

Participants are monitored for safety, effectiveness, and imaging biomarkers post-treatment

12 months

Follow-up visits at 1, 4-9, and 12 months

Extension/Long-term follow-up

Participants may continue to be monitored for long-term outcomes and safety

Beyond 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Yttrium-90 Radiation Segmentectomy (Y90 RS)

Trial Overview

The study is testing Yttrium-90 Radiation Segmentectomy, a treatment where tiny glass beads carrying radiation are delivered directly to parts of the liver with cancer. The goal is to find the best dose needed to destroy these tumors.

How Is the Trial Designed?

Group I: Cirrhotic Active Control 1 Intervention

Cirrhotic patients will begin at 300 Gy. Dose escalation will proceed in 100 Gy increments within each arm, with safety continuously evaluated by the Data Safety Monitoring Committee

Group II: Non-cirrhotic Active Control 1 Intervention

Non-cirrhotic patients will begin at a dose of 200 Gy. Dose escalation will proceed in 100 Gy increments within each arm, with safety continuously evaluated by the Data Safety Monitoring Committee.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Radiological Society of North America

Collaborator

Trials

27

Recruited

1,000+

Northwestern University Feinberg School of Medicine

Collaborator

Trials

42

Recruited

15,500+

Robert H. Lurie Cancer Center

Collaborator

Trials

23

Recruited

1,800+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7732555/

Yttrium-90 Radiation Segmentectomy - PMC - NIH

90 Y radiation segmentectomy is a novel adaptation of conventional radioembolization, which has demonstrated high tumor response rates with low toxicity.

2.

jvir.org

jvir.org/article/S1051-0443(23)00216-6/fulltext

Yttrium-90 Radiation Segmentectomy of Hepatocellular ...

Resin-based yttrium-90 (90Y) ablative transarterial radioembolization, also known as radiation segmentectomy (RS), can deliver safety and effectiveness profiles ...

3.

pubs.rsna.org

pubs.rsna.org/doi/abs/10.1148/radiol.231386

Efficacy and Safety of Radiation Segmentectomy with 90 Y ...

(A) Two-year survival for patients with prior treatment was 40%, whereas survival for treatment-naive patients and those without vascular ...

4.

evtoday.com

evtoday.com/articles/2025-oct/current-and-expanding-applications-of-radiation-segmentectomy

Current and Expanding Applications of Radiation ...

Initially a palliative therapy for patients with advanced liver cancer, transarterial radioembolization (TARE) with yttrium-90 (Y90) is now used as a potential ...

5.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1076633223003574

Long-term Clinical Outcomes of Yttrium-90 Transarterial ...

At 6 months post-treatment, 77.3% of patients were downstaged to or maintained Milan criteria, which was sustained for 74.4% and 70.0% of patients 1 year and 2 ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10854641/

Radiation Segmentectomy for the Treatment of Hepatocellular ...

Radiation segmentectomy is a versatile, safe, and effective ablative therapy for early-stage hepatocellular carcinoma.

7.

advancesradonc.org

advancesradonc.org/article/S2452-1094(25)00271-4/fulltext

Safety and Efficacy of External Beam Radiation Therapy in ...

Data on the safety and efficacy of external beam radiation therapy (EBRT) after yttrium 90 transarterial radioembolization (TARE) for hepatocellular carcinoma ( ...