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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

Tracking Information
First Submitted Date November 17, 2017
First Posted Date November 22, 2017
Last Update Posted Date April 25, 2018
Actual Study Start Date December 1, 2017
Actual Primary Completion Date January 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 17, 2017)
tumeur response [ Time Frame: 1 day ]
tumeur response
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03349957 on Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title TACE for HCC by TANDEM and Idarubicin
Official Title Retrospective Study on TACE for HCC by TANDEM and Idarubicin
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

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients treated by TACE for HCC by TANDEM and idarubicin
Condition Hepatocellular Carcinoma (HCC)
Intervention Drug: Transarterial chemoembolization using TANDEM and idarubicin
Transarterial chemoembolization using TANDEM and idarubicin
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 17, 2017)
Original Estimated Enrollment Same as current
Actual Study Completion Date March 30, 2018
Actual Primary Completion Date January 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

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

Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
Administrative Information
NCT Number NCT03349957
Other Study ID Numbers RECHMPL17_0390
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Plan Description: NC
Responsible Party University Hospital, Montpellier
Study Sponsor University Hospital, Montpellier
Collaborators Not Provided
Principal Investigator: Boris GUIU, MD, PhD University Hospital, Montpellier
PRS Account University Hospital, Montpellier
Verification Date November 2017