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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by Fudan University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Fudan University
ClinicalTrials.gov Identifier:
NCT00460681
First received: April 13, 2007
Last updated: October 30, 2007
Last verified: October 2007
  Purpose

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.


Condition Intervention Phase
Hepatocellular Carcinoma
Drug: Thymopentin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Phase III Study of Thymopentin in Patients After Curative Resection of Small

Further study details as provided by Fudan University:

Primary Outcome Measures:
  • disease-free survival [ Time Frame: three year ]

Secondary Outcome Measures:
  • overall survival [ Time Frame: three year ]

Estimated Enrollment: 220
Study Start Date: February 2007
Estimated Study Completion Date: February 2012
Intervention Details:
    Drug: Thymopentin
    subcutaneously or intramuscular inject at the dosage of 10 mg every second day (twice a week) for consecutive 3 months.
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 are a leading cause of liver cirrhosis and hepatocellular carcinoma. Surgical resection provides a potentially curative outcome for patients who are indicated to this procedure; however, survival is far from satisfactory because of the high recurrence rate, which is approximately 38-65% during the first 5 years, even for small HCC resection , it is still as high as 43.5%,and contributed to the major cause of mortality. Several approaches have been reported to decrease the recurrence rate after curative resection of HCC, such as postoperative transcatheter arterial chemoembolization (TACE) , chemotherapy , cyclic retinoic acid , and adoptive immunotherapy . However, these approaches are either controversial or require further evaluation , a substantial need for novel treatments is required urgently.

Tumor-induced immuno-suppression leads to an imbalance within the immune system, which closely related to the HCC recurrence and metastasis after resection, and an effective response is needed to eliminate residual tumor cells after removal of the major tumor tissue by surgery. Immunomodulatory peptides, like thymopentin (TP5), may act as immunomodulatory agents in cancer chemotherapy. TP5 comprises the amino acids (Arg-Lys-Asp-Val-Tyr) and represents residues 32-36 of the nuclear protein thymopoietin (TP) . A multitude of in vivo studies have shown efficacy of TP5 treatment in the therapy of various diseases including neoplastic, immune deficiency, autoimmune, and recurrent viral diseases etc. It rectifies imbalances in the immune system without observable side effects, even at very high doses. Furthermore, TP5 is able to significantly inhibit proliferation and induce apoptosis in some type of cancer lines.

Thus TP5 can not only act as an immunomodulatory factor in cancer chemotherapy or anti-HBV therapy, but also has potential as a chemotherapeutic agent in human cancer therapy

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00460681

Contacts
Contact: S J Qiu, MD +86-21-64037181 qiusj68@zshospital.com

Locations
China, Shanghai
Liver Cancer Institute and Zhongshan Hospital, Fudan University Recruiting
Shanghai, Shanghai, China, 200032
Contact: S J Qiu, MD    +86-21-64037181    qiusj68@zshospital.com   
Sponsors and Collaborators
Fudan University
Investigators
Study Director: Jia Fan, MD Liver Cancer Institute and Zhongshan Hospital, Fudan University, 200032, Shanghai, China.
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00460681     History of Changes
Other Study ID Numbers: ZSH-LCI-FJ-0001
Study First Received: April 13, 2007
Last Updated: October 30, 2007
Health Authority: China: Food and Drug Administration

Keywords provided by Fudan University:
Hepatocellular Carcinoma
Thymopentin
Recurrence
Resection

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Thymopentin
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014