SIRT with Y-90 Microspheres for Liver Cancer

(DOORwaY90 Trial)

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

100 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests tiny radioactive beads to treat liver cancer in patients who can't have surgery. The beads are injected into the liver and release radiation directly to the tumor to help control its growth. These beads have been used to deliver high doses of radiation directly to the tumor.

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 data supports the effectiveness of the treatment SIRT with Y-90 Microspheres for Liver Cancer?

Research shows that using yttrium-90 resin microspheres can help control liver tumors and improve survival in patients with liver cancer, such as hepatocellular carcinoma and metastatic colorectal cancer. This treatment has been effective in managing advanced liver cancers and is being studied further for its benefits. ^{1 2 3 4 5}

Is SIRT with Y-90 microspheres safe for humans?

Studies show that SIRT with Y-90 resin microspheres is generally safe for treating liver cancer, as it targets tumors while sparing healthy tissue. Safety data from trials indicate it is a well-tolerated treatment option for patients with advanced liver cancer. ^{1 5 6 7 8}

What makes the SIRT with Y-90 microspheres treatment unique for liver cancer?

This treatment is unique because it uses tiny resin beads loaded with a radioactive substance called yttrium-90, which are delivered directly to the liver tumor through the bloodstream, allowing for targeted radiation therapy that minimizes damage to surrounding healthy tissue. ^{1 2 5 9 10}

Research Team

Armeen Mahvash, MD

Principal Investigator

M.D. Anderson Cancer Center

S Cheenu Kappadath, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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.

My liver cancer diagnosis was confirmed by specific imaging or tissue analysis.

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

You have experienced serious allergic reactions or have had bad reactions to contrast agents, narcotics, or sedatives in the past.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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 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]

References

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

Radioembolization using 90Y-resin microspheres for patients with advanced hepatocellular carcinoma. [2022]

2. 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]

3. China pubmed.ncbi.nlm.nih.gov

Pretreatment tumor volume as a prognostic factor in metastatic colorectal cancer treated with selective internal radiation to the liver using yttrium-90 resin microspheres. [2022]

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

Efficacy and Tolerability of Selective Internal Radiotherapy With Yttrium-90 as Consolidation Treatment After Chemotherapy in Metastatic Colorectal Cancer. [2021]

5. China pubmed.ncbi.nlm.nih.gov

Selective internal radiation therapy with SIR-Spheres in hepatocellular carcinoma and cholangiocarcinoma. [2020]

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

Feasibility of Boosted Radioembolization for Hepatocellular Carcinoma Larger than 5 cm. [2019]

7. 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]

8. England pubmed.ncbi.nlm.nih.gov

A prospective, multicenter, open-label, single-arm clinical trial design to evaluate the safety and efficacy of 90Y resin microspheres for the treatment of unresectable HCC: the DOORwaY90 (Duration Of Objective Response with arterial Ytrrium-90) study. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Personalized 90 Y-resin microspheres dose determination: a retrospective study on the impact of dosimetry software on the treatment of patients with selective internal radiotherapy. [2023]

10. 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]