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

NCT00460681 | Unknown Phase 3 DMC

• 1 other identifier: ZSH-LCI-FJ-0001
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma; Thymopentin; Recurrence; Resection

Outcome Measures

Primary Outcomes (1)

• disease-free survival

  three year

Secondary Outcomes (1)

• overall survival

  three year

Interventions

Thymopentin DRUG

subcutaneously or intramuscular inject at the dosage of 10 mg every second day (twice a week) for consecutive 3 months.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Liver Cancer Institute and Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Recurrence

Interventions

Thymopentin

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thymopoietins; Thymus Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Jia Fan, MD

  Liver Cancer Institute and Zhongshan Hospital, Fudan University, 200032, Shanghai, China.

  STUDY DIRECTOR

Central Study Contacts

S J Qiu, MD

CONTACT

+86-21-64037181; qiusj68@zshospital.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 13, 2007
• First Posted: April 16, 2007
• Study Start: February 1, 2007
• Study Completion: February 1, 2012
• Last Updated: October 31, 2007

Record last verified: 2007-10

Locations

CN (1)