SIRT with Y-90 Microspheres for Liver Cancer

(DOORwaY90 Trial)

Not currently recruiting at 22 trial locations

Overseen By Steve J Chartier

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sirtex Medical

Must not be taking: Immunotherapy, Targeted therapy

Disqualifiers: Portal vein thrombosis, Extrahepatic disease, Clotting disorders, others

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: 2

Duration: Immediate procedure

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to treat liver cancer using tiny beads filled with a radioactive substance called Y-90. These beads, known as SIR-Spheres (resin microspheres containing yttrium-90), aim to control tumors that cannot be surgically removed by targeting them directly in the liver. The trial seeks patients with specific types of liver cancer, such as hepatocellular carcinoma (HCC), who have not received certain prior treatments or whose cancer has returned after specific treatments. Suitable participants might have a large liver tumor (up to 8 cm) but no major blood vessel involvement and relatively stable liver function. As an unphased trial, this study offers patients the chance to explore innovative treatment options that are not yet widely available.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it does exclude patients who have had prior systemic anti-cancer therapy, so it's best to discuss your specific medications with the trial team.

What prior data suggests that SIRT with Y-90 microspheres is safe for liver cancer treatment?

Research has shown that SIR-Spheres Y-90 resin microspheres are generally safe for treating liver cancer. These tiny beads deliver radiation directly to the tumor and are well-tolerated by most patients.

In one study, patients with liver cancer who received this treatment experienced relatively few serious side effects. Because the treatment targets the liver directly, it limits exposure to the rest of the body. Another study found that while some side effects occurred, they were usually manageable and not severe.

The FDA has already approved SIR-Spheres for certain liver cancer cases, indicating that experts have determined their safety. This approval confirms that the treatment has undergone thorough testing to ensure its safe use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for liver cancer, such as surgery, chemotherapy, or radiofrequency ablation, the treatment using Y-90 microspheres offers a unique approach by employing targeted radiation. These tiny resin spheres contain yttrium-90, a radioactive substance, and are delivered directly into the liver's blood vessels. This method allows the radiation to attack the cancer cells from within, sparing much of the surrounding healthy tissue. Researchers are excited about this treatment because it combines the precision of localized therapy with the power of radiation, potentially leading to fewer side effects and improved outcomes for patients.

What evidence suggests that SIRT with Y-90 microspheres is effective for liver cancer?

Studies have shown that SIR-Spheres Y-90 resin microspheres effectively treat liver cancer. This treatment uses tiny beads filled with the radioactive material yttrium-90 to target and shrink liver tumors. Research indicates that patients with liver cancer who received this treatment experienced significant tumor reduction. The FDA has approved this method for patients whose liver cancer cannot be surgically removed. This approval, along with positive results from previous studies, suggests that SIR-Spheres Y-90 can help control liver cancer growth. ^{1 5 6 7 8}

Who Is on the Research Team?

Armeen Mahvash, MD

Principal Investigator

M.D. Anderson Cancer Center

S Cheenu Kappadath, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Hemoglobin > 8.5 g/dL

I am fully active or can carry out light work.

White Blood Cell (WBC) ≥ 3 x 10^9/L

Exclusion Criteria

I have issues with my bile ducts or have had procedures on them.

Patients with drug or alcohol dependency (within 6 months prior to study entry) in the opinion of the investigator

I am currently being treated for another type of cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive hepatic arterial injection of SIR-Spheres Y-90 resin microspheres

Immediate procedure

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Visits at 1, 2, 4, 6, 9, 12, and 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Resin microspheres containing yttrium-90 (Y-90)

Trial Overview 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.

How Is the Trial Designed?

Group I: Open-label Single Arm Experimental Treatment 1 Intervention

Open-label single arm study evaluating treatment with hepatic arterial injection of SIR-Spheres.

Who Is Running the Clinical Trial?

Sirtex Medical

Lead Sponsor

Trials

30

Recruited

4,300+

Bright Research Partners

Industry Sponsor

Trials

18

Recruited

2,700+

Published Research Related to This Trial

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]

Selective internal radiation therapy (SIRT) using yttrium-90 (Y-90) resin microspheres shows promise as a treatment option for patients with intermediate and late-stage hepatocellular carcinoma (HCC) and intrahepatic cholangiocarcinoma (ICC), where traditional treatments may be limited.

Current literature indicates that SIRT is effective in targeting liver tumors while minimizing damage to surrounding healthy tissue, highlighting its potential safety and efficacy in managing these challenging cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Selective internal radiation therapy with SIR-Spheres in hepatocellular carcinoma and cholangiocarcinoma. Wang, EA., Broadwell, SR., Bellavia, RJ., et al.[2020]

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 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 68 patients with colorectal liver metastases, those who received selective internal radiotherapy (SIRT) after first-line chemotherapy had a significantly longer median progression-free survival of 9 months compared to just 3 months for those who received SIRT after two or more lines of chemotherapy.

SIRT was found to be safe, with no grade 3 or higher adverse events reported, indicating that it is a valid treatment option for patients with colorectal liver metastases, especially when used earlier in the treatment process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Tolerability of Selective Internal Radiotherapy With Yttrium-90 as Consolidation Treatment After Chemotherapy in Metastatic Colorectal Cancer. Cortesi, E., Caponnetto, S., Masi, G., et al.[2021]

Citations

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

Yttrium-90 Microspheres for Intermediate- or Advanced-Stage ... The objective of this report is to evaluate the evidence regarding the clinical effectiveness and cost-effectiveness of TARE using 90Y microspheres to support ...

2. 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.

3. onclive.com onclive.com/view/fda-approves-y-90-resin-microspheres-for-unresectable-hcc

FDA Approves Y-90 Resin Microspheres for Unresectable ... The FDA has approved SIR-Spheres Y-90 resin microspheres for the treatment of patients with unresectable hepatocellular carcinoma (HCC).

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04736121

Study Details | NCT04736121 | Selective Internal Radiation ... The objective of this pivotal study is to evaluate the safety and effectiveness of SIRT using SIR-Spheres Y-90 resin microspheres as first-line treatment ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12005707/

The Impact of Radiation Dose and Tumour Burden on ... Patients who subsequently received curative therapies after being downstaged by Y-90 RE had remarkable clinical outcomes. Keywords: Liver cancer, Hepatocellular ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC1845138/

Safety and efficacy of Y-90 microsphere treatment in patients ... In this study we have retrospectively reviewed the clinical data on patients who underwent whole-liver SIRT with Y-90 resin microspheres and ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf/P990065S014D.pdf

SIR-Spheres® Y-90 resin microspheres SIR-Spheres Y-90 resin microspheres are indicated for the local tumor control of unresectable hepatocellular carcinoma (HCC) in patients with no macrovascular ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4688348/

Outcomes and Predictors of Toxicity after Selective Internal ... We sought to report outcomes and toxicity in patients with hepatocellular carcinoma (HCC) who received resin yttrium-90 selective internal radiation therapy ...