HepaSphere™ Microspheres Prospective Registry

NCT04866290 | Completed Results

• 1 other identifier: CRC-P4-16-01
• Study Type: observational
• Target: 105
• Locations: 2 countries
• Sites: 2

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.

Conditions

Metastatic Colorectal Cancer

Keywords

Colorectal Cancer; Liver metastases; Transarterial chemoembolization

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  Median overall survival of subjects treated with HepaSphere Microspheres loaded with irinotecan. Analysis will be performed when all subjects enrolled have been followed for survival for two years (24 months), are considered lost to follow up, or have died, whichever comes first

  24 months

Secondary Outcomes (4)

• Objective Response Rate (ORR)

  24 months

• Best Tumor Response

  24 months

• Liver Progression-free Survival

  24 months

• Time to Progression

  24 months

Interventions

HepaSphere Microspheres DEVICE

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with unresectable metastatic colorectal cancer with metastases to the liver.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merit Medical Systems, Inc.: lead

Study Sites (2)

European Hospital Georges Pompidou

Paris, 75015, France

Location

Evgenidio Hospital/ATTIKO Hospital

Athens, 11528, Greece

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Results Point of Contact

• Title: Vicky Brunk RN, Vice President, Medical Affairs, Merit Medical
• Organization: Merit Medical Systems, Inc.

vicky.brunk@merit.com

+1 (717) 873-3309

Study Officials

• Katerina Malagari, MD

  Evgenidio Hospital/ATTIKO Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: April 29, 2021
• Study Start: September 22, 2016
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: April 3, 2023
• Results First Posted: October 12, 2022

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1); FR (1)