HepaSphere™ Microspheres Prospective Registry

NCT ID: NCT04866290

Last Updated: 2023-04-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 105 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-09-22
• Study Completion Date: 2021-06-30

Brief Summary

HepaSphere™ Microspheres loaded with irinotecan received CE mark for the indication of use in embolization of metastatic colorectal cancer (mCRC) to the liver in 2015.

The purpose of this registry is to demonstrate the safety and efficacy of HepaSphere Microspheres loaded with irinotecan for the treatment of colorectal liver metastasis and add to the understanding of the use and value of this treatment in 'real life' usage conditions.

Detailed Description

This prospective, post-market study was designed to evaluate the median overall survival (MOS) of subjects with metastatic colorectal cancer (mCRC) to the liver treated with HepaSphere Microspheres loaded with the chemotherapeutic agent irinotecan. This treatment process is referred to as transarterial chemoembolization (TACE).

Subjects with confirmed colorectal cancer liver metastases that were ineligible for surgical hepatic tumor resection and that had not undergone prior TACE for this indication were considered for study participation. Patients that met eligibility criteria, wanted to participate in the study, and signed the informed consent form (ICF) made up the study subject population. All study subjects were in one cohort and were not blinded to treatment.

Per protocol, all subjects completed a baseline visit to collect medical history information, lab assessments, and have a baseline MRI. Following this baseline visit subjects were to have two TACE cycles (i.e., TACE Cycle 1, TACE Cycle 2), with TACE Cycle 2 occurring within 2-4 weeks following TACE Cycle 1. A TACE cycle is defined as one TACE procedure for subjects with unilobar disease or two TACE procedures for subjects with bilobar disease (i.e., one for each lobe of the liver). Following completion of TACE Cycle 1 and TACE Cycle 2, additional TACE cycles could be performed at the investigator's discretion for residual or new disease.

When subjects had completed two TACE cycles and were no longer indicated for further TACE cycles (at the investigator's discretion), they entered follow-up. The study ended and analysis began when all enrolled subjects had (1) completed two-year (24 months) follow-up from the date of TACE Cycle 1, (2) been deemed lost to follow up, or (3) died, whichever occurred first.

Conditions

Metastatic Colorectal Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

HepaSphere Microspheres

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Histologically or radiologically confirmed colorectal cancer metastases to the liver
• Patient is able to have either CT or MRI imaging
• Hepatic tumor burden ≥50% of total tumor burden
• Hepatic tumor burden ≤50% of total liver volume
• Not suitable for treatment by resection or percutaneous ablation at time of TACE treatment
• Life expectancy ≥ 3 months
• WHO performance status ≤ 2

Exclusion Criteria

• Previous treatment with any form of hepatic transarterial embolization
• Total bilirubin ≥ 3.0 mg/dL
• Any contraindication for irinotecan administration
• Partial or complete thrombosis of the main portal vein
• Cardiovascular or respiratory failure
• Any other condition deemed exclusionary by the Investigator

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merit Medical Systems, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Katerina Malagari, MD

Role: PRINCIPAL_INVESTIGATOR

Evgenidio Hospital/ATTIKO Hospital

Locations

European Hospital Georges Pompidou

Paris, , France

Evgenidio Hospital/ATTIKO Hospital

Athens, , Greece

Countries

France; Greece

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CRC-P4-16-01

Identifier Type: -

Identifier Source: org_study_id