A Randomized Phase III, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of Everolimus (RAD001) in Adult Patients With Advanced Hepatocellular Carcinoma After Failure of Sorafenib Treatment - The EVOLVE-1 Study

Inclusion Criteria:

1. Advanced liver cancer

2. Prior systemic treatment with sorafenib for advanced HCC and for whom their disease
progressed during or after sorafenib treatment, or were intolerant to sorafenib
treatment. Specifically, this can be defined as:

- Documented radiological confirmation (radiology scans or report) of disease
progression during or after sorafenib treatment

- Intolerance to sorafenib (at any dose and/or duration) is defined as documented
sorafenib-related grade 3 or 4 adverse events that led to sorafenib
discontinuation.

NOTE:

- Sorafenib must be the last antineoplastic treatment before randomization

- Prior local and/or hormonal therapy (e.g., tamoxifen) before sorafenib is
allowed

- One systemic chemotherapy regimen for advanced HCC is allowed before sorafenib
treatment

3. ECOG performance status of ≤ 2

4. Child-Pugh A

Exclusion Criteria:

- Active bleeding during the last 28 days

- Prior therapy with mTOR inhibitors

- Prior liver or other organ transplantation which mandates systemic immunosuppression
Other protocol-defined inclusion/exclusion criteria may apply