A randomised placebo-controlled, double blinded, phase III trial of sorafenib in combination with transarterial chemoembolisation in hepatocellular cancer. - TACE-2

• Conditions: Hepatocellular Carcinoma, non-resectable; MedDRA version: 13.1Level: LLTClassification code 10019828Term: Hepatocellular carcinoma non-resectableSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2008-005073-36-GB
• Lead Sponsor: niversity College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-15
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 412

Inclusion 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 the RECIST criteria by CT-scan or MRI. • Not a candidate for surgical resection • Aged = 18 years and estimated life expectancy >3 months • ECOG performance status = 1 • Adequate haematological function Hb = 9g/L, absolute neutrophil count =1.5x109/L, platelet count = 60x109/L • Bilirubin = 50 µmol/L, AST and ALT = 5 x ULN, ALP < 4 x ULN • Adequate renal function; Creatinine = 1.5 x ULN • INR = 1.5 • Amylase < 2 x ULN • Child-Pugh A (score = 6) • Left Ventricular Ejection Fraction = 45% • Women of child-bearing potential should have a negative pregnancy test prior to study entry. Both men and women must be using an adequate contraception method, which must be continued for 3 months after completion of treatment • Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Extrahepatic metastasis • Prior embolisation, systemic or radiation therapy for HCC • Any contraindications for hepatic embolisation procedures procedures including portosystemic shunt, hepatofugal blood flow, known severe atheromatosis. • Investigational therapy or major surgery within 4 weeks of trial entry • Any ablative therapy (RFA or PEI ) for HCC (this should not exclude patients if target lesion(s) have not been treated and occurred >6 weeks prior study entry) • History of bleeding within the past 4 weeks • Child-Pugh cirrhosis C or B (score <7) • Hepatic encephalopathy • Ascites refractory to diuretic therapy • Documented occlusion of the hepatic artery or main portal vein • Hypersensitivity to intravenous contrast agents • Active clinically serious infection > Grade 2 NCI-CTC version 4 • Pregnant or lactating women • Known history of HIV infection • History of second malignancy except those treated with curative intent more than three years preciously without relapse and non-melanotic skin cancer or cervical carcinoma in situ • Evidence of severe or uncontrolled systemic diseases, cardiac arrhythmias (requiring anti-arrhythmic therapy or pace maker), uncontrolled hypertension, congestive cardiac failure >NYHA class 2, MI within 6 months or laboratory finding that in the view of the Investigator makes it undesirable for the patient to participate in the trial • Psychiatric or other disorder likely to impact on informed consent • Patient is unable and/or unwilling to comply with treatment and study instructions • Patient unable to swallow oral medications

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified