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NCT Number: NCT04903548

Evaluating the Effects of Selective Treatment Utilizing Flex-dosing for Unresectable HCC With Y90 SIR-Spheres

The overall objective of this research study is to evaluate outcomes associated with flex-dosing in Y90 SIR-Sphere administration in a prospective cohort of unresectable HCC patients eligible for segmental/super selective treatment at Methodist Dallas Medical Center (MDMC).

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

About this study

The overall objective of this research study is to evaluate outcomes associated with flex-dosing in Y90 SIR-Sphere administration in a prospective cohort of unresectable HCC patients eligible for segmental/super selective treatment at Methodist Dallas Medical Center (MDMC).

This study will enable physicians to be more precise in administering the correct radio-embolic dose, which will improve safety and efficacy of treatment while maintaining optimal dosing for tumor side effects. This study could potentially identify tumors earlier in the course of disease progression, which may result in more efficacious treatment and quality of life for patients. Earlier diagnosis and treatment may result in decreased costs.

This is a prospective cohort registry study. The prospective study cases will include all eligible Y90 patients, who meet the inclusion criteria who are treated beginning in May 2020 to May 2022. Follow-up of patients included in study will continue as needed in order to evaluate survival outcomes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 years or older
  • All patients diagnosed with unresectable HCC in two of fewer hepatic segments at MDMC who undergo at least one SIRT procedure with Y-90 resin microspheres (SIR-Spheres®, Sirtex Medical Limited, Sydney, Australia) will be included in data capture. HCC is considered unresectable if it is multifocal or bilobar, or if the patient has malignant portal vein thrombosis, portal hypertension, or decompensated liver disease (Child-Pugh B or C).
  • Eligible cases for inclusion are those that would have undergone Y-90 resin SIRT and had an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2; platelets >60,000; creatinine <2 mg/dL; bilirubin <2 mg/dL; and international normalized ratio (INR) <1.2.

Exclusion criteria

  • Subjects that do not meet the inclusion criteria
  • Patients are not eligible for SIRT if they had any extrahepatic disease; contraindication to hepatic artery catheterization such as vascular abnormalities, bleeding diathesis, allergy to contrast dye, concurrent malignancy, refractory ascites, previous external beam radiation, or evidence of any uncorrectable flow to the gastrointestinal tract; or greater than 30 Gy of radiation estimated to be delivered to the lung based on angiography or Tc-99 microaggregated albumin scan (shunt fraction of 20% or greater).

Treatment and study plan

SIRT with Y-90 resin microspheres

Procedure

Selective internal radiation therapy (SIRT) with Y-90 resin microspheres (Y-90 resin SIRT) is an intra-arterial, catheter-based locoregional therapy that has been used to treat patients with unresectable HCC

Primary outcomes

  1. Patient demographics

    Time frame: May 2020 - 2022

    Patient demographics

  2. Volumes for liver to be treated

    Time frame: May 2020 - 2022

    liver volume prior to treatment

  3. Lobe/segment to be treated

    Time frame: May 2020 - 2022

    treatment location

  4. Tumor volume

    Time frame: May 2020 - 2022

    volume of tumor prior to treatment

  5. Lung Shunt

    Time frame: May 2020 - 2022

    Lung shunt presence

  6. Tumor to normal ratio Tumor to Normal ratio prior to greatment

    Time frame: May 2020 - 2022

    T:N

  7. Severity of liver disease

    Time frame: May 2020 - 2022

    Child-Pugh score

  8. Liver synthetic function

    Time frame: May 2020 - 2022

    ALBI (albumin-bilirubin) score

  9. Objective response rate

    Time frame: May 2020 - 2022

    using modified response evaluation criteria in solid tumors

  10. Progression-free survival

    Time frame: May 2020 - 2022

    Progression-free survival

  11. Overall survival

    Time frame: May 2020 - 2022

    Overall survival

  12. Hospital-based charges/costs

    Time frame: May 2020 - 2022

    Hospital-based charges/costs

  13. Liver function tests

    Time frame: May 2020 - 2022

    Measurement of Alanine transaminase (ALT), Aspartate transaminase (AST), Alkaline phosphatase (ALP), Albumin and total protein, Bilirubin, Prothrombin time (PT), L-lactate dehydrogenase (LD), Gamma-glutamyltransferase (GGT)

  14. SPECT CT

    Time frame: May 2020 - 2022

    for missed Y90 administrations or extrahepatic Y90

Sponsors and collaborators

Lead sponsor

Methodist Health System

Other

Registry information

Official study title

Evaluating the Effects of Segmental/Super Selective Treatment Utilizing Flex-dosing in Treating Unresectable HCC With Y90 SIR-Spheres

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
May 26, 2021
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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