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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)

Conditions

Liver | Liver Cancer

Trial Phase

Phase III

Trial Purpose and Description

Trial Purpose

To compare Progression-Free Survival (PFS) of chemoembolization alone to sorafenib in combination with chemoembolization.


Participation Guidelines

Age:
18 Years and older
Gender:
Both

Eligibility Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sponsor:
Eastern Cooperative Oncology Group
 
National Cancer Institute (NCI)
Dates:
04/07/2011
Last Updated:
Study HIC#:
1102008042