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Trial record 12 of 255 for:    IDARUBICIN

TACE for HCC by TANDEM and Idarubicin (TANDEM-IDA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03349957
Recruitment Status : Completed
First Posted : November 22, 2017
Last Update Posted : April 25, 2018
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief Summary:

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

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Study Type : Observational
Actual Enrollment : 98 participants
Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: Transarterial chemoembolization using TANDEM and idarubicin
    Transarterial chemoembolization using TANDEM and idarubicin

Primary Outcome Measures :
  1. tumeur response [ Time Frame: 1 day ]
    tumeur response

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients treated by TACE for HCC by TANDEM and idarubicin

Inclusion Criteria:

HCC according to histological examination or Barcelona criteria Measurable targets according to mRECIST v1.1 Child A or B7 cirrhosis (without decompensation in the past 6 months) HCC not candidate to surgery or ablation Age ≥ 18 years Performance status 0 or 1 Thrombocytes ≥ 50 000/mm3, neutrophil count≥ 1 000/mm3, creatininemia ≤ 150 µmol/L No cardiac failure

Exclusion Criteria:

Follow-up < 1month Lobar/main portal venous thrombus Prior treatment by systemic chemotherapy or radioembolization

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03349957

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Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
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Principal Investigator: Boris GUIU, MD, PhD University Hospital, Montpellier

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Responsible Party: University Hospital, Montpellier Identifier: NCT03349957     History of Changes
Other Study ID Numbers: RECHMPL17_0390
First Posted: November 22, 2017    Key Record Dates
Last Update Posted: April 25, 2018
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: NC

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Montpellier:

Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action