Y-90 Radioembolization for Liver Cancer

Overseen By Ching-Wei Tzeng, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Extrahepatic disease, Portal hypertension, Cirrhosis, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety of using Yttrium-90 (Y-90) resin microspheres to treat liver cancer, specifically targeting tumors on the right side of the liver. The goal is to determine if this treatment can control the tumors and promote growth in the cancer-free left side of the liver, preparing it for possible surgery. The study seeks participants with colorectal liver metastases who have been advised that surgery might be an option but require more liver volume first. Participants should have completed at least two months of chemotherapy and be prepared to sign a consent form. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative approach.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since participants must have received at least four cycles of chemotherapy, it seems that continuing certain treatments might be necessary. Please consult with the trial coordinators for specific guidance.

What prior data suggests that Y-90 TARE is safe for liver cancer treatment?

Research has shown that Yttrium-90 (Y-90) resin microspheres are generally well-tolerated by patients. These tiny radioactive beads are used in selective internal radiation therapy (SIRT) and have been found to be safe. For example, one study found that most patients experienced mild to moderate side effects like tiredness and nausea, common with many cancer treatments, while serious side effects were less common.

Another study examined Y-90 use in patients with liver cancer and found that severe complications were rare. This indicates that while risks exist, the treatment is considered safe for most patients.

Y-90 resin microspheres have already been approved for treating certain types of liver cancer, further supporting their safety. However, as with any treatment, discussing potential risks with a healthcare provider is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike standard treatments for liver cancer, which often involve chemotherapy or surgery, Yttrium-90 (Y-90) resin microspheres offer a unique approach through targeted radioembolization. This treatment uses tiny radioactive beads to deliver radiation directly to the cancerous areas in the liver, sparing healthy tissue and potentially reducing side effects. Researchers are excited about Y-90 because it allows for precise targeting of tumors on the right side of the liver, while the unaffected left side can continue to function and grow normally. This targeted approach could lead to improved outcomes and a better quality of life for patients.

What evidence suggests that Y-90 resin microspheres might be an effective treatment for liver cancer?

Research has shown that Yttrium-90 (Y-90) resin microspheres, the treatment under study in this trial, can effectively control liver tumors. Studies have found that this treatment works well for people with liver cancer by directly targeting tumors with radiation. Y-90 has been particularly successful in treating hepatocellular carcinoma, a type of liver cancer, without causing serious side effects. It delivers a high dose of radiation to the tumor, helping to shrink it and stop its growth. These findings suggest that Y-90 could be a promising option for managing liver cancer and potentially improving survival rates. ^{1 2 6 7 8}

Who Is on the Research Team?

Ching-Wei Tzeng, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for patients with colorectal liver metastases (CLM) who need surgery but have insufficient future liver remnant (FLR). Candidates must be medically fit for operation, mentally competent to consent, and have potentially curable CLM without extensive extrahepatic disease. They should not be pregnant or breastfeeding, nor suffer from conditions like high bilirubin levels, low platelets, albumin deficiency, portal hypertension or cirrhosis.

Inclusion Criteria

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

My surgeon says I am fit for surgery.

I need a procedure to prepare my liver for a major surgery aimed at curing me.

Exclusion Criteria

I have symptoms from colon or rectal cancer and do not have an ostomy.

Starting total bilirubin >1.3 mg/dL (except if patient has Gilbert's Disease)

I have no medical reasons preventing me from having liver surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Y-90 Radioembolization Treatment

Y-90 TARE directed to the right hemi-liver for induction of left liver FLR hypertrophy

6 weeks

1 visit (in-person)

Surgical Intervention

Planned single-stage or two-stage hepatectomy for patients with CLM

Varies

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Yttrium-90 (Y-90) resin microspheres

Trial Overview The study tests the safety of Y-90 TARE (radioembolization) in controlling tumors on one side of the liver and stimulating growth in the other part before a major hepatectomy. It's designed for those whose FLR is too small initially and aims to make a single-stage or two-stage liver resection possible.

How Is the Trial Designed?

Group I: Yttrium-90 Experimental Treatment 1 Intervention

Help to control the tumor(s) on the right side of the liver while the remaining left side of the liver, which is clear of cancer, grows.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Sirtex Medical

Industry Sponsor

Trials

30

Recruited

4,300+

Published Research Related to This Trial

In a study of 111 patients with unresectable hepatocellular carcinoma (HCC) treated with Y-90 resin microspheres, factors such as early-stage disease and absence of complications like portal vein thrombosis were linked to significantly longer overall survival, with patients in the early-stage group living an average of 27.8 months compared to just 9.2 months for those in advanced stages.

Y-90 resin treatment was generally well-tolerated, with adverse events reported in 23 patients shortly after treatment and 46 patients at 3 months, indicating that while some side effects occurred, the therapy was manageable and could be an effective option for bridging patients to liver transplantation, which further improved survival outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Selective internal radiation therapy using yttrium-90 resin microspheres in patients with unresectable hepatocellular carcinoma: a retrospective study. Mantry, PS., Mehta, A., Madani, B., et al.[2022]

In a study involving 28 patients with unresectable hepatocellular carcinoma (HCC), Y-90 microsphere therapy demonstrated safety and efficacy, with no significant complications observed during or shortly after treatment.

The therapy resulted in a complete response in 7% of patients and a partial response in 36%, indicating that it can effectively target liver tumors while minimizing damage to healthy tissue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Yttrium-90 (Y-90) Resin Microsphere Therapy for Patients with Unresectable Hepatocellular Carcinoma: a Single-Center Experience. İnce, S., Karaman, B., Alagoz, E., et al.[2019]

In a study of 88 patients with hepatocellular carcinoma treated with yttrium 90 microspheres (TheraSpheres), 42% experienced liver toxicities, with higher risks associated with elevated pretreatment total bilirubin levels and increased liver radiation doses.

Despite the occurrence of liver toxicities, most resolved over time, and no patients developed confirmed radiation-induced liver disease, indicating that doses up to 150 Gy for a single treatment and 268 Gy for repeated treatments were well tolerated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of unresectable hepatocellular carcinoma with intrahepatic yttrium 90 microspheres: factors associated with liver toxicities. Goin, JE., Salem, R., Carr, BI., et al.[2019]

Selective intraarterial radionuclide therapy (SIRT) using Yttrium-90 microspheres is a safe and effective treatment for unresectable hepatic metastases from neuroendocrine tumors, with a high overall response rate of 90% in a study of 10 patients.

The treatment delivered a significant dose of radiation directly to the tumors (mean 99.73 Gy) while minimizing exposure to healthy liver tissue (mean 26.73 Gy) and lungs (mean 4.45 Gy), indicating its targeted approach reduces potential side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Selective intraarterial radionuclide therapy with Yttrium-90 (Y-90) microspheres for hepatic neuroendocrine metastases: initial experience at a single center. Arslan, N., Emi, M., Alagöz, E., et al.[2019]

Selective internal radiotherapy (SIRT) using yttrium-90 microspheres can enhance clinical outcomes for patients with inoperable liver cancer by targeting tumors while protecting healthy tissue.

Effective planning for SIRT is crucial to avoid serious side effects like radiation-induced liver disease, and it is recommended to use multiple planning methods to determine the appropriate microsphere activity for each patient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient selection and activity planning guide for selective internal radiotherapy with yttrium-90 resin microspheres. Lau, WY., Kennedy, AS., Kim, YH., et al.[2022]

In a study of 60 patients with liver metastases from colorectal cancer, higher prescribed activity of Yttrium-90 resin microspheres was associated with improved radiographic tumor response at 4-6 months post-treatment, as measured by RECIST criteria.

Overall survival was not significantly linked to the prescribed activity or dose, suggesting that while the treatment may improve tumor response, it does not necessarily extend survival, highlighting the need for better dose calculation models for predicting treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Correlation of radiation dose and activity with clinical outcomes in metastatic colorectal cancer after selective internal radiation therapy using yttrium-90 resin microspheres. Badiyan, S., Bhooshan, N., Chuong, MD., et al.[2019]

In a study involving 34 patients with unresectable hepatocellular carcinoma (HCC), Yttrium-90 (Y-90) microsphere therapy demonstrated significant efficacy, with 19% achieving complete response and 44% showing partial response after treatment.

The therapy was found to be safe, with no serious side effects reported, and predictors of treatment success included mean tumor dose delivery and the absence of bilobar disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Yttrium-90 (Y-90) resin microsphere therapy for patients with unresectable hepatocellular carcinoma. Identification of successful treatment response predictors and patient selection. Arslan, N., Ince, S., Okuyucu, K., et al.[2022]

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.4_suppl.581

Selective internal radiation therapy with yttrium-90 resin ... This study aimed to evaluate the efficacy and safety of selective internal radiation therapy (SIRT) with yttrium-90 resin microspheres followed ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2542568421000441

Clinical outcome of Yttrium-90 selective internal radiation ... Y-90 SIRT is an effective treatment for the local tumor control of HCC without serious adverse events. Single lesion, AFP level and ECOG status were predictors ...

3. pubs.rsna.org pubs.rsna.org/doi/full/10.1148/radiol.231386

Efficacy and Safety of Radiation Segmentectomy with 90 Y ... Patients with hepatocellular carcinoma who underwent radiation segmentectomy with yttrium 90 resin microspheres received a median tumor absorbed dose of 232 Gy.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5674259/

Selective internal radiation therapy using yttrium-90 resin ... Survival after yttrium-90 resin microsphere radioembolization of hepatocellular carcinoma across Barcelona clinic liver cancer stages: a European evaluation.

5. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK571551/

Yttrium-90 Microspheres for Intermediate- or Advanced-Stage ... Evidence regarding the cost-effectiveness of 90Y microspheres for treating hepatocellular carcinoma is conflicting. Three economic evaluations suggest treatment ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1743919121002296

Selective internal radiation therapy with yttrium 90 resin ... The objective of this systematic review and expert consensus statement is to provide guidance and perspectives on the use of SIRT among patients with HCC in ...

7. accscience.com accscience.com/journal/ARNM/1/1/10.36922/arnm.0385

Safety and effectiveness of selective internal radiation ... The study aimed to evaluate the safety and effectiveness of selective internal radiation therapy (SIRT) in patients with unresectable hepatocellular carcinoma ...

8. jgo.amegroups.org jgo.amegroups.org/article/view/10538/html

Selective internal radiation therapy with SIR-Spheres in ... This article outlines mechanisms involved in SIRT administration and reviews key efficacy and safety data that are currently available in the literature.