SorAfenib Versus RADIOEMBOLIZATION in Advanced Hepatocellular Carcinoma

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether RADIOEMBOLIZATION with 90 Yttrium microspheres is more effective on overall survival in advanced Hepatocellular carcinoma (HCC) with or without portal venous obstruction and no extrahepatic extension than sorafenib which is now the standard treatment of advanced HCC.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborator: Ministry of Health, France
• Treatments: Niacinamide; Sorafenib

Criteria

Inclusion Criteria:

• Histological or cytological diagnosis or meet the AASLD criteria for diagnosis of HCC and at least one uni-dimensional lesion measurable according to RECIST criteria by CT-scan or MRI

• Adult over 18 years old and estimated life expectancy over 3 months

• Patient with advanced HCC according to BCLC staging system (stage C) with or without portal vein thrombosis, not eligible for surgical resection, liver transplantation nor radiofrequency ablation OR patient with progression or recurrence of HCC after surgical or locoregional treatment not eligible for surgical resection, liver transplantation nor radiofrequency ablation OR patients in whom chemoembolisation has failed after two courses (patients who have received only one course of chemoembolisation are eligible if the failure of the first round shows that a second round will have no more impact; patients who have received more than two courses of chemoembolisation are still eligible if the arterial network is perfectly normal on a CT scan in the arterial phase). Failure is defined as the absence of an objective response after two courses of treatment in the treated nodule (objective response according to modified RECIST criteria and/or EASL criteria).

• ECOG performance status under or equals 1

• Adequate haematological function: Hb over or equals 9g/100mL, absolute neutrophil count over or equals 1 500/mm3, platelet count over or equals 50 000/mm3

• Adequate renal function; serum creatinine under 150μmol/L

• Bilirubin under or equals 50 µmol/L, AST or ALT uner or equals 5 x ULN, INR under or equals 1.5

• Liver cirrhosis Child Pugh A - B7

• written informed consent

Exclusion Criteria:

• Another primary tumour, with the exception of conventional basal cell carcinoma or superficial bladder neoplasia

• Extrahepatic metastasis

• Advanced HCC previously treated

• Advanced liver disease with Child-Pugh score over 7 or active gastrointestinal bleeding or encephalopathy or ascites refractory to diuretic therapy Women who are pregnant or breast feeding

• Allergy to contrast media

• Contraindication to hepatic artery catheterisation, such as severe peripheral vascular disease precluding catheterisation

• Psychiatric or other disorder likely to impact on informed consent

• Patient unable and/or unwilling to comply with treatment and study instructions

• Patient unable to swallow oral medications