A Phase III Study of Sorafenib plus Doxorubicin versus Sorafenib Alone in Patients with Advanced Hepatocellular Cancer

Full Title

Phase III Randomized Study of Sorafenib Plus Doxorubicin Versus Sorafenib in Patients with Advanced Hepatocellular Carcinoma (HCC)(CALGB 80802)


Sorafenib is drug approved for the treatment of a form of liver cancer called hepatocellular carcinoma (HCC). Doxorubicin is an anticancer drug commonly used to treat a variety of cancers. In this study, investigators want to determine if adding doxorubicin to sorafenib is more effective than sorafenib alone for patients with advanced HCC that has spread and has not responded to treatments such as surgery or local therapies.

Sorafenib is taken orally (by mouth). Doxorubicin is given by vein. Patients will be randomly assigned to receive sorafenib alone or with doxorubicin.

This study is sponsored by the National Cancer Institute, who will provide sorafenib for all patients in the study.


To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have locally advanced or metastatic HCC that has not responded to surgery or local therapies.
  • Patients may not have had systemic therapy for metastatic disease, nor prior treatment with sorafenib or other drugs that work by inhibiting Raf or VEGF.
  • At least 4 weeks must have passed since completion of prior treatments and entry into the study.
  • Patients must be able to be ambulatory for more than half of their normal waking hours.
  • Patients must be age 18 or older

For more information and to inquire about eligibility for this study, please contact Dr. Ghassan Abou-Alfa at 646-888-4184.