Chemoembolisation of Non Resectable, Non Metastatic Hepatocellular Carcinomas

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire Dijon
• Treatments: Idarubicin

Criteria

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