TACE for HCC by TANDEM and Idarubicin

Hepatocellular Carcinoma (HCC) Clinical Trial

— TANDEM-IDA  

Official title:

Retrospective Study on TACE for HCC by TANDEM and Idarubicin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03349957
• Other study ID #: RECHMPL17_0390
• Status: Completed
• First received: November 17, 2017
• Last updated: April 23, 2018
• Start date: December 1, 2017
• Est. completion date: March 30, 2018

Study information

• Verified date: November 2017
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: March 30, 2018
• Est. primary completion date: January 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma (HCC)

Intervention

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

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	tumeur response	tumeur response	1 day