Safety and Efficacy of RAD001 + TACE in Localized Unresectable HCC

A Phase II Randomized, Double-blinded, Multicenter Asian Study Investigating the Combination of Transcatheter Arterial Chemoembolization (TACE) and Oral Everolimus (RAD001, Afinitor®) in Localised Unresectable Hepatocellular Carcinoma (HCC) - The TRACER Study

This study will evaluate the role of everolimus in combination with local Transcatheter Arterial Chemoembolization (TACE) procedure in patients with localized unresectable Hepatocellular Carcinoma (HCC).

Inclusion Criteria:

• Newly diagnosed hepatocellular carcinoma limited to liver and not suitable for resection, liver transplant, or radiofrequency ablation.
• Intermediate stage (stage B) (according to recognized guidelines) and suitable for TACE therapy
• At least one nodule between > 2cm and ≤ 15cm in diameter with no vascular invasion or abdominal lymph node or distant metastases.
• Must have 1 tumor which can be measured in 1 dimension according to specified criteria (RECIST and mRECIST) and has not previously been treated with any type of therapy.
• ECOG performance status < 2cm
• Cirrhotic status of Child-Pugh class A or early B
• HBV-DNA or HBsAg positive at screen or baseline: preventative treatment with anti-viral started 1-2 weeks prior to receiving study drug

Exclusion Criteria:

• Any local and/or investigational drugs within 28 days prior to randomization
• Active bleeding during the last 28 days prior to screening including variceal bleeding
• Prior therapy with mTOR inhibitors
• Tumor burden of > 60% liver involvement
• Prior systemic or local therapy including TACE except for the first TACE at Day 0), surgery or liver transplantation
• Failed first TACE at Day 0, Cycle 1 for any reason
• Known history of human immunodeficiency virus (HIV) seropositivity (HIV testing is not mandatory)
• Alcohol intake of 80 grams per day
• Undergone major surgery ≤ 3 weeks prior to starting study drug or who have not recovered from surgery
• Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods

Other protocol-defined inclusion/exclusion criteria may apply