Ignite Creation Date:
2024-05-05 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00460681
Status:
UNKNOWN
Last Update Posted:
2007-10-31
First Post:
2007-04-13
Brief Title:
Study of Thymopentin in Patients After Curative Resection of Small Hepatocellular Carcinoma
Sponsor:
Fudan University
Organization:
Fudan University
Study Overview
Official Title:
Phase III Study of Thymopentin in Patients After Curative Resection of Small
Status:
UNKNOWN
Status Verified Date:
2007-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 HBVChronic 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 435and 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None