Clareo Health | Global Study Looking at the Combination of RAD001 Plus Best Supportive Care (BSC) and Placebo Plus BSC to Treat Patients With Advanced Hepatocellular Carcinoma.
Global Study Looking at the Combination of RAD001 Plus Best Supportive Care (BSC) and Placebo Plus BSC to Treat Patients With Advanced Hepatocellular Carcinoma.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis Pharmaceuticals
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Advanced liver cancer
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
* ECOG performance status of ≤ 2
* Child-Pugh A
You may not be if
Active bleeding during the last 28 days
Prior therapy with mTOR inhibitors
Prior liver or other organ transplantation which mandates systemic immunosuppression