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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04813861
Other study ID # 2020-PI199-99
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 4, 2010
Est. completion date March 2021

Study information

Verified date March 2021
Source Central Hospital, Nancy, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 57
Est. completion date March 2021
Est. primary completion date December 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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) Exclusion Criteria: - Combined treatment over one year following the last TACE - No baseline, in between or after combined treatment imaging - Lesion appeared after TACE treatment

Study Design


Locations

Country Name City State
France CHRU de Nancy Nancy

Sponsors (1)

Lead Sponsor Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Lesion Response Lesion response after combined treatment 4-6 weeks after BWA or RFA or 3-6 months after CK
Secondary Delayed Lesion Response Lesion response a year after combined treatment 1 year after BWA, RFA or CK
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