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TACE for HCC by TANDEM and Idarubicin

NCT03349957 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 98

Last updated 2018-04-25

No results posted yet for this study

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

Conditions

  • Hepatocellular Carcinoma (HCC)

Interventions

DRUG

Transarterial chemoembolization using TANDEM and idarubicin

Transarterial chemoembolization using TANDEM and idarubicin

Sponsors & Collaborators

  • University Hospital, Montpellier

    lead OTHER

Principal Investigators

  • Boris GUIU, MD, PhD · University Hospital, Montpellier

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-01
Primary Completion
2018-01-30
Completion
2018-03-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03349957 on ClinicalTrials.gov