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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04903548
• Other study ID #: 017.HEP.2020.D
• Status: Recruiting
• Start date: April 20, 2021
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Methodist Health System
• Contact: Crystee Cooper, DHEd
• Phone: 214-947-1280
• Email: ClinicalResearch[@]mhd.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

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

Locations

Country	Name	City	State
United States	Methodist Dallas Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

Outcome

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