5063S-11: E1208 liver

CTSU E1208: A Phase III Randomized, Double-Blind Trial of Chemoembolization with or without Sorafenib in Unresectable Hepatocellular Carcinoma (HCC) in Patients with and without Vascular Invasion

Type of Study
Cancer (Oncology) - Liver
Location
Swedish Cancer Institute
Short Description

Purpose: This randomized phase III trial is studying chemoembolization and sorafenib tosylate to see how well they work compared with chemoembolization alone in treating patients with liver cancer that cannot be removed by surgery.

 

Read and print the E1208-patient study summary

Status
Open to Enrollment
Principal Investigator
Gary Goodman, M.D.
Eligibility Notes
  • Diagnosis of hepatocellular carcinoma (HCC) according to 1 of the following criteria:
    • Histologically confirmed disease
    • Liver cirrhosis AND ≥ 1 solid liver lesion > 2 cm with early enhancement and delayed enhancement washout on CT scan or MRI regardless of alpha-fetoprotein levels (AFP)
    • AFP > 400 ng/mL AND ≥ 1 solid liver lesion > 2 cm regardless of specific imaging characteristics on CT scan or MRI
  • Disease must be limited to the liver
    • No clinical or radiographic evidence of extrahepatic HCC
    • Portal vein lymphadenopathy is allowed for patients with hepatitis B or C
  • Branch portal vein invasion by tumor allowed
    • No main portal vein invasion by tumor
  • Child Pugh score of A or B7 within the past 4 weeks
  • Not a candidate for curative resection, orthotopic liver transplantation, or radiofrequency ablation (RFA)
  • No prior brachytherapy (e.g., yttrium-90 microspheres)
  • No prior sorafenib tosylate, chemoembolization, or systemic chemotherapy, including cytotoxic agents or molecularly targeted agents
  • Prior attempted curative liver resection allowed
  • More than 4 weeks since prior RFA
  • No concurrent cytochrome P450 enzyme-inducing drugs
  • No concurrent prophylactic G-CSF or GM-CSF
More Info Link
Additional information about the study summary and eligibility criteria may be viewed on the U.S. National Institutes of Health (NIH) website.
Phone
(206) 215-3086
Email
CancerResearch@swedish.org