Status:
UNKNOWN
Study of Thymopentin in Patients After Curative Resection of Small Hepatocellular Carcinoma
Lead Sponsor:
Fudan University
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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.
Detailed Description
Hepatocellular carcinoma (HCC) is one of the most prevalent malignancies in China, and approximately 90% of the patients with HCC are also infected with hepatitis B virus (HBV).Chronic HBV infections ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2012
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT00460681
Start Date
February 1 2007
End Date
February 1 2012
Last Update
October 31 2007
Active Locations (1)
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1
Liver Cancer Institute and Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200032