Y-90 Radioembolization for Liver Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Ching-Wei Tzeng, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Extrahepatic disease, Portal hypertension, Cirrhosis, others

No Placebo Group

Approved in 3 Jurisdictions

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.

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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.

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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.

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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.

Trial 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

Participant Groups

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.

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

M D Anderson Cancer Center Houston, TX

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center Lead Sponsor

Sirtex Medical Industry Sponsor

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] Selective internal radiation therapy (SIRT) with yttrium-90 resin (Y-90 resin) microspheres has been used as a locoregional therapy for patients with unresectable hepatocellular carcinoma (HCC). We examined patient and disease characteristics that might affect survival after Y-90 resin, as well as treatment tolerability.

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

Patient selection and activity planning guide for selective internal radiotherapy with yttrium-90 resin microspheres. [2022] Selective internal radiotherapy (SIRT) with yttrium-90 ((90)Y) resin microspheres can improve the clinical outcomes for selected patients with inoperable liver cancer. This technique involves intra-arterial delivery of β-emitting microspheres into hepatocellular carcinomas or liver metastases while sparing uninvolved structures. Its unique mode of action, including both (90)Y brachytherapy and embolization of neoplastic microvasculature, necessitates activity planning methods specific to SIRT.

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] Selective intraarterial radionuclide therapy (SIRT) with yttrium-90 (Y-90) resin microspheres presently has successful results in primary or metastatic inoperable liver tumors. This procedure, which is also known as radioembolisation, delivers high doses of radiation selectively to hepatic tumors while minimum healthy liver exposure. The aim of this study was to present our clinical experience of radiomicrosphere therapy for the treatment of patients with unresectable hepatocellular carcinoma (HCC).

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] Selective intraarterial radionuclide therapy (SIRT) with Yttrium-90 (Y-90) resin microspheres has been applied for hepatocellular carcinoma (HCC) lately. The aim of this study is to present our clinical experience of radiomicrosphere therapy in the treatment of unresectable HCC and determine the proper cases who could benefit from this therapy according to response results yielded by initial staging and control imaging modalities.

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] Yttrium-90 (Y)-resin microspheres are prescribed using activity. We evaluated overall survival (OS) and radiographic tumor response after selective internal radiation therapy (SIRT) with resin microspheres in patients with liver metastases from colorectal cancer.

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

Treatment of unresectable hepatocellular carcinoma with intrahepatic yttrium 90 microspheres: factors associated with liver toxicities. [2019] Intraarterial injection of yttrium 90 microspheres (TheraSpheres) is used in the treatment of hepatocellular carcinoma (HCC). This article presents an analysis of the incidence of liver toxicities (liver-related events) and pretreatment factors associated with liver toxicities after TheraSphere treatment.

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] Selective intraarterial radionuclide therapy (SIRT) with Yttrium-90 (Y-90) microspheres is also known as radioembolization and delivers high doses of radiation to hepatic tumors with minimum healthy liver exposure. The aim of this study was to present our preliminary experience in the role of liver directed radiotherapy with Y-90 microspheres for the treatment of unresectable hepatic metastases from neuroendocrine tumors (NET).