NCT03053596

Brief Summary

The main purpose of this registry is to assess liver toxicity, treatment efficacy, and safety of DEB-TACE using anthracyclin loaded LifePearls for treatment of patients with unresectable hepatocellular carcinoma allocated to TACE treatment.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2016

Typical duration for all trials

Geographic Reach
2 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 14, 2016

Completed
18 days until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 15, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 8, 2019

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

2.4 years

First QC Date

October 14, 2016

Last Update Submit

January 24, 2020

Conditions

Hepatocellular Carcinoma

Keywords

HCCLifePearl

Outcome Measures

Primary Outcomes (1)

  • Liver toxicity assessment based on routine CT scans

    12 months

Secondary Outcomes (4)

  • Liver toxicity assessment based on routine blood tests: liver enzymes, phosphatase alkaline, GGT, CBC, bilirubin, albumin. Number of participants with changes in liver function related to TACE treatment.

    12 months

  • Treatment efficacy based on response rate assessed by mRECIST criteria

    3 months after final TACE

  • Treatment efficacy based on response rate assessed by RECIST 1.1 criteria

    3 months after final TACE

  • Safety based on recorded SAE assessed by CTCAE v4.03

    12 months

Interventions

DEB-TACE using anthracyclin loaded LifePearl™DEVICE

The main purpose of this registry is to assess liver toxicity, treatment efficacy, and safety of DEB-TACE using anthracyclin loaded LifePearl™ for treatment of patients with unresectable hepatocellular carcinoma allocated to TACE treatment at multidisciplinary tumor board.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with unresectable hepatocellular carcinoma allocated to TACE treatment at multidisciplinary tumor board.

You may qualify if:

  • Patients, more than 18 years old, with unresectable hepatocellular carcinoma eligible for treatment with anthracyclin loaded LifePearls, allocated to TACE treatment at multidisciplinary tumor board and who agree to data collection in the registry by signing informed consent form.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Cliniques Universitaires Saint Luc

Brussels, Belgium

Location

Hôpital Erasme

Brussels, Belgium

Location

Hôpital Beaujon

Clinchamp, France

Location

CHRU Lille

Lille, France

Location

Hôpital Universitaire Saint-Eloi

Montpellier, France

Location

Hôpital L'Archet II

Nice, France

Location

Institut Gustave Roussy

Villejuif, France

Location

Related Publications (1)

  • de Baere T, Guiu B, Ronot M, Chevallier P, Sergent G, Tancredi I, Tselikas L, Dioguardi Burgio M, Raynaud L, Deschamps F, Verset G. Real Life Prospective Evaluation of New Drug-Eluting Platform for Chemoembolization of Patients with Hepatocellular Carcinoma: PARIS Registry. Cancers (Basel). 2020 Nov 17;12(11):3405. doi: 10.3390/cancers12113405.

    PMID: 33212917DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Thierry de Baere, MD

    Institut Gustave Roussy, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2016

First Posted

February 15, 2017

Study Start

November 1, 2016

Primary Completion

April 1, 2019

Study Completion

October 8, 2019

Last Updated

January 27, 2020

Record last verified: 2020-01

Locations

FR(5)BE(2)