NCT04813861

Brief Summary

Hepatocellular carcinoma (HCC) can present itself in many forms (size, number of lesions) for the treatment of which a therapeutic panel can be elaborated and layered. If a curative treatment cannot be considered in case of an HCC classified in an intermediate stage, a Transcatheter Arterial Chemoembolization (TACE) can be proposed. In case of a partial response or the treatment of some lesions of a multifocal HCC, a combined treatment by stereotaxic radiotherapy (CK), radiofrequency ablation (RFA) or microwave ablation (MWA) may be initiated in accordance with a decision of the multidisciplinary consultation meeting. The aim of this study was to evaluate the clinical outcome of HCC receiving MWA, RFA or CK after downstaging with TACE.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

January 4, 2010

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

March 21, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 24, 2021

Completed
Last Updated

March 24, 2021

Status Verified

March 1, 2021

Enrollment Period

9.9 years

First QC Date

March 21, 2021

Last Update Submit

March 21, 2021

Conditions

Keywords

Hepatocellular CarcinomaTransarterial ChemoembolizationStereotactic body radiotherapyRadiofrequency AblationMicrowave Ablation

Outcome Measures

Primary Outcomes (1)

  • Lesion Response

    Lesion response after combined treatment

    4-6 weeks after BWA or RFA or 3-6 months after CK

Secondary Outcomes (1)

  • Delayed Lesion Response

    1 year after BWA, RFA or CK

Eligibility Criteria

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

Patients who have been treated for HCC by TACE, followed by additional treatment with RFA, MWA or CK in the following year, between January 2010 and December 2020 by Nancy Regional University Hospital (TACE, RFA, MWA) and Lorraine Institute of Cancer (CK)

You may qualify if:

  • a HCC treated by TACE followed by RFA, MWA and/or CK
  • from 01/2010 to 12/2020
  • treated by Nancy Regional University Hospital (TACE, RFA, MWA) and Institut de Cancérologie de Lorraine (CK)

You may not qualify if:

  • Combined treatment over one year following the last TACE
  • No baseline, in between or after combined treatment imaging
  • Lesion appeared after TACE treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Nancy

Nancy, 54000, France

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

March 21, 2021

First Posted

March 24, 2021

Study Start

January 4, 2010

Primary Completion

December 1, 2019

Study Completion

March 1, 2021

Last Updated

March 24, 2021

Record last verified: 2021-03

Locations