Capecitabine to Prevent Recurrence of Hepatocellular Carcinoma After Curative Resection

• Status: Unknown status
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether capecitabine is effective to prevent disease recurrence after curative hepatic resection in patients with hepatocellular carcinoma.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: Capecitabine

Criteria

Inclusion Criteria:

• First curative hepatic resection

• Hepatocellular Carcinoma (histologically confirmed)

• Cirrhosis of Child-Pugh class A or B

• A performance status ≤ 2

• Adequate bone marrow ,hepatic and renal functions (white blood cell (WBC) count > 2.5×10^3/μL, platelet count > 40×10^3/μL, a serum bilirubin level, alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 2 times the upper limit of the normal value, and serum creatinine level < 1.5 mg/dL)

• Major organ (heart, lung and brain) function was normal

• An age between 18 and 79 years.

Exclusion Criteria:

• Any active infectious process

• Known hypersensitivity to capecitabine

• The presence of clinically confirmed extrahepatic metastasis, macroscopic evidence of tumor thrombus in the inferior vena cava or the main portal vein or the main bile duct

• Other previous or synchronous malignant disorders

• Postoperative dysfunction of any organ.