List All Liver Cancer Trials

Liver Cancer

RAD001 for Advanced Hepatocellular Carcinoma (UW09040)
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
Status Conditions Phase Study ID
Closed Hepatocellular Carcinoma (Liver Cancer) Phase III UW09040

The purpose of this study is to compare treatment with RAD001 plus best supportive care (BSC) to placebo plus BSC in patients with advanced HCC whose disease progressed while on or after sorafenib treatment or who are intolerant to sorafenib.

Samuel Whiting, MD, PhD
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.


    • 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
Exclusions (conditions that would prevent participation in this study)

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


Last Updated
May 25, 2012
See this trial at
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.