Clinical trial NCT04903548: Evaluating the Effects of Selective Treatment Utilizing Flex-dosing for Unresectable HCC with Y90 SIR-Spheres
Official title: Evaluating the Effects of Segmental/super Selective Treatment Utilizing Flex-dosing in Treating Unresectable HCC with Y90 SIR-Spheres
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2021-05-26
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

Brief 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).

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Patient demographics
timeFrame: May 2020 - 2022
measure: Volumes for liver to be treated
timeFrame: May 2020 - 2022
measure: Lobe/segment to be treated
timeFrame: May 2020 - 2022
measure: Tumor volume
timeFrame: May 2020 - 2022
measure: Lung Shunt
timeFrame: May 2020 - 2022
measure: Tumor to normal ratio Tumor to Normal ratio prior to greatment
timeFrame: May 2020 - 2022
measure: Severity of liver disease
timeFrame: May 2020 - 2022
measure: Liver synthetic function
timeFrame: May 2020 - 2022
measure: Objective response rate
timeFrame: May 2020 - 2022
measure: Progression-free survival
timeFrame: May 2020 - 2022
measure: Overall survival
timeFrame: May 2020 - 2022
measure: Hospital-based charges/costs
timeFrame: May 2020 - 2022
measure: Liver function tests
timeFrame: May 2020 - 2022
measure: SPECT CT
timeFrame: May 2020 - 2022
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Methodist Dallas Medical Center
state: Texas
Study officials:
affiliation: Methodist Health System
name: Parvez Mantry, MD
role: PRINCIPAL_INVESTIGATOR
References: