A Phase III Randomized, Placebo Controlled, Double Blind Trial of Sorafenib Plus Erlotinib vs. Sorafenib Plus Placebo as First Line Systemic Treatment for Hepatocellular Carcinoma (HCC)
A Phase III Randomized, Placebo Controlled, Double Blind Trial of Sorafenib Plus Erlotinib vs. Sorafenib Plus Placebo as First Line Systemic Treatment for Hepatocellular Carcinoma (HCC)
This is a randomized trial to evaluate the clinical benefit of sorafenib 400 mg twice daily and erlotinib 150 mg once a day versus sorafenib 400 mg twice daily and placebo erlotinib once daily in subjects with unresectable advanced or metastatic Child-Pugh A HCC. Patients who are candidates for potentially curative intervention (i.e. surgical resection or local ablation) are not eligible for this study.
European quality of life scale (5 dimensions) (EQ-5D)
Inclusion Criteria:
Patients > 18 years of age
Patients who have a life expectancy of at least 12 weeks
Patients with histological or cytologically documented HCC
Patients must have at least one tumor lesion that meets both of the following criteria:
Patients who have an ECOG PS (Eastern Cooperative Oncology Group Performance Status) of 0 or 1
Cirrhotic status of Child-Pugh class A.
Patients who give written informed consent prior to any study specific screening procedures with the understanding that the patient has the right to withdraw from the study at any time.
Exclusion Criteria:
Bruxelles - Brussel, 1200, Belgium
Zrifin, 70300, Israel
Wellington South, 6021, New Zealand