A Phase III Randomized Trial of Chemoembolization with or without Sorafenib in Unresectable Hepatocellular Carcinoma (HCC) in Patients with and without Vascular Invasion (ECOG 1208)
Trial Purpose and Description
To compare Progression-Free Survival (PFS) of chemoembolization alone to sorafenib in combination with chemoembolization.
- 18 Years and older
- Patients must have a diagnosis of hepatocellular carcinoma by at least one criterion listed below:
i. Histologically confirmed
ii. Magnetic Resonance Imaging (MRI) or Computerized Tomography (CT) consistent with liver cirrhosis and at least one solid liver lesion > 2cm with early enhancement and delayed enhancement washout regardless of alpha-feto protein levels (AFP).
iii. AFP > 400ng/mL and evidence of at least one solid liver lesion > 2cm regardless of specific imaging characteristics on CT or MRI
HCC limited to the liver. There must be no clinical or radiographic evidence of extrahepatic HCC.
Portal Lymphadenopathy IS permitted for patients with HBV or HCV &ndash as lymphadenopathy is commonly associated with hepatitis unrelated to malignancy.
Patients may have been treated with RFA in the past, but no sooner than 4 weeks before study registration
Patients must have a life expectancy of at least 3 months
Patients must have an ECOG performance status of 0 or 1.
- Patients must not be known to be HIV positive drug-drug interactions with study medication and HIV medications is not well-characterized and could lead to unwanted side effects.
Prior treatment with sorafenib, chemoembolization, or systemic therapy
Prior treatment with brachytherapy
Ascites detectable on physical examination.
- Eastern Cooperative Oncology Group
- National Cancer Institute (NCI)
- Last Updated:
- Study HIC#: