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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

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

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Procedure: SIRT with Y-90 resin microspheres


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: SIRT with Y-90 resin microspheres|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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient demographics | Patient demographics | May 2020 - 2022 | 
| Volumes for liver to be treated | liver volume prior to treatment | May 2020 - 2022 | 
| Lobe/segment to be treated | treatment location | May 2020 - 2022 | 
| Tumor volume | volume of tumor prior to treatment | May 2020 - 2022 | 
| Lung Shunt | Lung shunt presence | May 2020 - 2022 | 
| Tumor to normal ratio Tumor to Normal ratio prior to greatment | T:N | May 2020 - 2022 | 
| Severity of liver disease | Child-Pugh score | May 2020 - 2022 | 
| Liver synthetic function | ALBI (albumin-bilirubin) score | May 2020 - 2022 | 
| Objective response rate | using modified response evaluation criteria in solid tumors | May 2020 - 2022 | 
| Progression-free survival | Progression-free survival | May 2020 - 2022 | 
| Overall survival | Overall survival | May 2020 - 2022 | 
| Hospital-based charges/costs | Hospital-based charges/costs | May 2020 - 2022 | 
| Liver function tests | 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) | May 2020 - 2022 | 
| SPECT CT | for missed Y90 administrations or extrahepatic Y90 | May 2020 - 2022 |