Status:
COMPLETED
SorAfenib Versus RADIOEMBOLIZATION in Advanced Hepatocellular Carcinoma
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Ministry of Health, France
Conditions:
Liver Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
Detailed Description
Background: In patients with advanced hepatocellular carcinoma, sorafenib is now the standard treatment with an increased median overall survival but an overall incidence of treatment-related adverse ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
496 Patients enrolled
Trial Details
Trial ID
NCT01482442
Start Date
December 1 2011
End Date
April 1 2016
Last Update
January 16 2017
Active Locations (26)
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1
CHU Amiens #2
Amiens, Amiens, France, 80054
2
CHU Angers #3
Angers, Angers, France, 49933
3
CHRU Besançon Hôpital Jean Minjoz #21
Besançon, Besançon, France, 25030
4
Hôpital Jean Verdier #25
Bondy, Bondy, France, 93140