- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03349957
TACE for HCC by TANDEM and Idarubicin (TANDEM-IDA)
Retrospective Study on TACE for HCC by TANDEM and Idarubicin
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Montpellier, France, 34295
- Uhmontpellier
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
tumeur response
Time Frame: 1 day
|
tumeur response
|
1 day
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Boris GUIU, MD, PhD, University Hospital, Montpellier
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Digestive System Neoplasms
- Liver Diseases
- Liver Neoplasms
- Carcinoma, Hepatocellular
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Idarubicin
Other Study ID Numbers
- RECHMPL17_0390
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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