Study of Thymopentin in Patients After Curative Resection of Small Hepatocellular Carcinoma

• Status: Unknown status
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the clinical efficacy of thymopentin on the prevention of the recurrence and metastasis of small HCC after resection.

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

Details

• Lead Sponsor: Fudan University
• Treatments: Thymopentin

Criteria

Inclusion Criteria:

• Patients who received curative resection of HBV-related small HCC (pathologically proved, solitary tumour <5cm, or two/ tumours <5cm)

• Curative resection was defined as (1) the complete resection of all tumor nodules and the cut surface being free of cancer by histological examination; (2) no macroscopic cancerous thrombus was found in the portal vein (main trunk or two major branches), hepatic veins or bile duct, (3) no extrahepatic metastasis was found

• Evidence of a positive serum HBV profile but a negative test for anti-HCV antibody

• The major organ (heart, liver,lung and kidney) function was normal

Exclusion Criteria:

• History of cardiac disease

• Active clinically serious infection

• Known history of human immunodeficiency virus (HIV) infection

• Pregnant or breast-feeding patients

• Prior use of any systemic anti-cancer treatment for HCC, eg. Chemotherapy, immunotherapy or hormonal therapy (except that hormonal therapy for supportive care is permitted). Antiviral treatment is allowed, however interferon therapy must at least 4 weeks prior randomization

• Any condition that is unstable or which could jeopardize the safety of the patient and his / her compliance in the study