Chemoembolisation of Non Resectable, Non Metastatic Hepatocellular Carcinomas Combining DC Bead Microspheres Loaded With Idarubicin (Zavedos®): Phase I Trial
18 Years
N/A
Both
Carcinoma, Hepatocellular
Trial Information
Chemoembolisation of Non Resectable, Non Metastatic Hepatocellular Carcinomas Combining DC Bead Microspheres Loaded With Idarubicin (Zavedos®): Phase I Trial
Hepatocellular carcinoma (HCC) is the fifth most common malignancy and the third most common
cause of cancer-related death worldwide. Most of the patients are diagnosed at
intermediate-advanced stage when the sole standard treatment is transarterial
chemoembolization (TACE). In the literature, survival rates in TACE studies vary widely and
finally, there is no suggestion for the best chemotherapeutic agent or the optimal treatment
regimen.
We hypothesise that the use of idarubicin (the most cytotoxic drug on HCC cell lines) in DC
Bead would enhance the efficacy of TACE. The primary objective of the study is to determine
the maximal tolerated dose of idarubicin in DC Bead for chemoembolization of non resectable
non metastatic hepatocellular carcinoma.
Inclusion Criteria:
- Hepatocellular carcinoma cytologically or histologically proved or diagnosed
according the criteria of the American Association for the Study of Liver
Diseases(AASLD 2005)
- Three nodules maximum (unilobar disease without limitation in the number of nodules;
3 maximum nodules if bilobar disease [satellite nodules <1cm not included in the
total sum])
- Child-Pugh score A or B7
- ECOG Performance Status < 2
- Platelet count > 50,000/µl and absolute neutrophil count (ANC) >1,000/µl
- Serum creatinine < 150 µmol/l
- Resting ejection fraction > 50% (echocardiography or isotopic method)
- Age > 18 years
- Signed written informed consent
Exclusion Criteria:
- Patients eligible for surgical resection or hepatic transplantation or radiofrequency
ablation
- Extrahepatic metastases
- Known gastrointestinal bleeding up to 30 days before study entry
- Patients with anticoagulant treatment
- Evidence of portal vein thrombosis
- Pregnancy
- Clinically serious infection
- Known hypersensitivity to anthracyclines
- Known hypersensitivity to contrast medium
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Dose-limiting toxicity assessed according NCI CTC AE v3.0
Outcome Time Frame:
Within the first month after chemoembolization
Safety Issue:
Yes
Principal Investigator
Laurent BEDENNE, MD Ph.D
Investigator Role:
Principal Investigator
Investigator Affiliation:
Centre Hospitalier Universitaire de DIJON
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
IDASPHERE
NCT ID:
NCT01040559
Start Date:
December 2009
Completion Date:
June 2012
Related Keywords:
- Carcinoma, Hepatocellular
- Carcinoma
- Carcinoma, Hepatocellular
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