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TACE for HCC by TANDEM and Idarubicin

Retrospective Study on TACE for HCC by TANDEM and Idarubicin

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03349957
Acronym
TANDEM-IDA
Enrollment
98
Registered
2017-11-22
Start date
2017-12-01
Completion date
2018-03-30
Last updated
2018-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma (HCC)

Keywords

TACE

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

Interventions

DRUGTransarterial chemoembolization using TANDEM and idarubicin

Transarterial chemoembolization using TANDEM and idarubicin

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
tumeur response1 daytumeur response

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026