Carcinoma, Hepatocellular
Conditions
Brief summary
The purpose of this study is to determine the maximal tolerated dose of idarubicin for chemoembolization of non resectable non metastatic hepatocellular carcinoma.
Detailed description
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.
Interventions
DRUGidarubicin
Transarterial chemoembolization (in the hepatic artery) with idarubicin 5mg or 10 mg or 15 mg or 20 mg or 25 mg injected in a solution of 2ml DC Bead (300 µm-500µm); 1 unique course
Sponsors
Centre Hospitalier Universitaire Dijon
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicity assessed according NCI CTC AE v3.0 | Within the first month after chemoembolization |
Secondary
| Measure | Time frame |
|---|---|
| Objective responses according criteria of the European Association for the Study of the Liver and according RECIST criteria. | 2 months |
| Quality of life (EORTC QLQ-C30) | 2 months |
| Pharmacokinetics parameters of idarubicin and idarubicinol | Within 72 hours after chemioembolization |
Countries
France
Outcome results
None listed