A Study of Capecitabine (Xeloda) and Peginterferon Alfa-2a (Pegasys) in Treatment-Naive Participants With Advanced Liver Cancer

An Open-Label Phase II Study of Capecitabine in Combination With Pegylated Interferon Alfa-2a in Patients With Advanced Hepatocellular Carcinoma

This study will evaluate the efficacy and safety of capecitabine (Xeloda) in combination with peginterferon alfa-2a (Pegasys) in participants with advanced liver cancer who have had no prior treatment. The anticipated time on study treatment is until disease progression, and the target sample size is 43 individuals.

Inclusion Criteria:

• Adults 18 to 75 years of age
• Locally advanced or metastatic liver cancer with measurable disease and not eligible for any standard therapy

Exclusion Criteria:

• Previous treatment for liver cancer
• Main portal vein involvement
• Bone, brain, or leptomeningeal metastasis
• Clinically significant cardiac disease
• Malabsorption syndrome or lack of physical integrity of the upper gastrointestinal tract
• History of other cancer, except basal cell skin cancer or in situ cancer of the cervix