TACE for HCC by TANDEM and Idarubicin (TANDEM-IDA)
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|ClinicalTrials.gov Identifier: NCT03349957|
Recruitment Status : Completed
First Posted : November 22, 2017
Last Update Posted : April 25, 2018
DcBeads and lipiodol-transarterial chemoembolization (TACE) of hepatocellular carcinoma (HCC) using doxorubicin result in about 50% objective response rate at 6 months (Precision V study, Lammer et al. CVIR 2010) We previously demonstrated that idarubicin was the most effective drug on 3 HCC cell lines (Boulin et al., Anticancer drugs 2009). We tested idarubicin-loaded beads in a phase I trial (Boulin et al., Aliment Pharmacol Therapy 2012) and more recently in a prospective multicentric phase II trial (IDASPHERE II, Magna Cum Laude CIRSE 2017, B Guiu et al.). This trial was stopped at interim analysis because the endpoint was reached.
Tandem beads are precisely calibrated, of small size, allowing the maximization of ischemic effects together with an optimal efficacy of the drug. We previously published that idarubicin was able to load fastly in Tandem, with minimal modification of bead diameter and a very interesting releasing profile of the drug (Guiu et al., JVIR 2015).
We used TANDEM combined with idarubicin in our practice for the treatment of HCC by TACE (in-label use of beads and the drug).
No clinical study (even retrospective) has been published so far with TANDEM-IDA (except our first paper published in JVIR in 2015, only 4 patients).
Here we propose to collect the retrospective data of patients treated by TANDEM-IDA, to help to design a future multicentric randomized phase II trial
|Condition or disease||Intervention/treatment|
|Hepatocellular Carcinoma (HCC)||Drug: Transarterial chemoembolization using TANDEM and idarubicin|
|Study Type :||Observational|
|Actual Enrollment :||98 participants|
|Official Title:||Retrospective Study on TACE for HCC by TANDEM and Idarubicin|
|Actual Study Start Date :||December 1, 2017|
|Actual Primary Completion Date :||January 30, 2018|
|Actual Study Completion Date :||March 30, 2018|
- Drug: Transarterial chemoembolization using TANDEM and idarubicin
Transarterial chemoembolization using TANDEM and idarubicin
- tumeur response [ Time Frame: 1 day ]tumeur response
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03349957
|Montpellier, France, 34295|
|Principal Investigator:||Boris GUIU, MD, PhD||University Hospital, Montpellier|