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

Trial Summary

What is the purpose of this trial?

A prospective, interventional study evaluating the safety of Y-90 TARE for tumor control of the right side and induction of left liver hypertrophy as part of a planned single-stage or two-stage hepatectomy for patients with CLM and insufficient FLR at the time of presentation.

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 data supports the effectiveness of the treatment Y-90 Radioembolization for Liver Cancer?

Research shows that Yttrium-90 (Y-90) resin microspheres, used in Selective Internal Radiation Therapy (SIRT), can improve outcomes for patients with inoperable liver cancer, including hepatocellular carcinoma (HCC) and liver metastases from colorectal cancer, by delivering targeted radiation to tumors while sparing healthy liver tissue. ^{1 2 3 4 5}

Is Y-90 radioembolization safe for humans?

Y-90 radioembolization, also known as SIRT or TARE-Y90, has been used in treating liver cancer and is generally considered safe, but it can cause liver-related side effects. Studies have shown it delivers high doses of radiation to liver tumors while minimizing exposure to healthy liver tissue, though some patients may experience liver toxicities. ^{1 2 3 5 6}

How does Y-90 radioembolization treatment differ from other liver cancer treatments?

Y-90 radioembolization is unique because it delivers high doses of radiation directly to liver tumors through tiny beads, minimizing exposure to healthy liver tissue. This targeted approach, known as selective internal radiation therapy (SIRT), combines radiation therapy with embolization, which blocks blood flow to the tumor, making it different from traditional chemotherapy or external radiation treatments. ^{1 2 3 5 7}

Research Team

Ching-Wei Tzeng, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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]

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 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]

References

1. China pubmed.ncbi.nlm.nih.gov

Selective internal radiation therapy using yttrium-90 resin microspheres in patients with unresectable hepatocellular carcinoma: a retrospective study. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Patient selection and activity planning guide for selective internal radiotherapy with yttrium-90 resin microspheres. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Yttrium-90 (Y-90) Resin Microsphere Therapy for Patients with Unresectable Hepatocellular Carcinoma: a Single-Center Experience. [2019]

4. Italy 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. [2022]

5. England 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. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Treatment of unresectable hepatocellular carcinoma with intrahepatic yttrium 90 microspheres: factors associated with liver toxicities. [2019]

7. Serbia 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. [2019]