Sorafenib Plus Doxorubicin in Patients With Advanced Hepatocellular Carcinoma With Disease Progression on Sorafenib

Inclusion Criteria: * Diagnosis of HCC confirmed histologically, excluding mixed HCC histology (e.g. HCC plus cholangiocarcinoma) or fibrolamellar variant. * Prior treatment with sorafenib as single agent or in combination, with no less than 200 mg once every other day dose of sorafenib, with radiologic evidence of progression of disease. * Measurable disease using RECIST 1.1 criteria. * Non-cirrhotic or no more than Child-Pugh A cirrhosis. * Expected survival of at least 3 months. * Age ≥ 18 years. * KPS ≥ 70% * Fully recovered from any prior surgery and/or radiation and none within 2 weeks of initiating treatment. * Patients may have been treated with locoregional liver directed therapies such as embolization, chemo-embolization including drug-eluting beads doxorubicin chemoembolization (prior non drug eluting beads chemoembolization with doxorubicin is excluded), radiation, radioactive microspheres, etc., provided that they either have a target lesion that has not been subjected to local therapy and/or the target lesion(s) within the field of the local therapy has shown an increase of ≥25% in the size since last treatment. Such therapy must be completed at least 4 weeks prior to treatment initiation. Patients that have received palliative radiation therapy to the bone need not wait 4 weeks to begin protocol therapy. * Informed consent must be obtained prior to study initiation. * Total bilirubin ≤3.0 mg/dL and no evidence of bile obstruction. * Absolute neutrophil count (…