Chemoembolisation of Non Resectable, Non Metastatic Hepatocellular Carcinomas

Centre Hospitalier Universitaire Dijon18 enrolled

Overview

The purpose of this study is to determine the maximal tolerated dose of idarubicin for chemoembolization of non resectable non metastatic hepatocellular carcinoma.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Carcinoma, Hepatocellular

Interventions

idarubicinDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Centre Hospitalier Universitaire de DIJON

Dijon, Burgundy, France

Outcomes

Primary Outcomes

Dose-limiting toxicity assessed according NCI CTC AE v3.0

Time frame: Within the first month after chemoembolization

Secondary Outcomes

Objective responses according criteria of the European Association for the Study of the Liver and according RECIST criteria.

Time frame: 2 months

Quality of life (EORTC QLQ-C30)

Time frame: 2 months

Pharmacokinetics parameters of idarubicin and idarubicinol

Time frame: Within 72 hours after chemioembolization

Data from ClinicalTrials.gov

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