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Phase III Study of Thymopentin in Patients After Curative Resection of Small

Phase 3
18 Years
75 Years
Open (Enrolling)
Hepatocellular Carcinoma

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Trial Information

Phase III Study of Thymopentin in Patients After Curative Resection of Small

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

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

disease-free survival

Outcome Time Frame:

three year

Principal Investigator

Jia Fan, MD

Investigator Role:

Study Director

Investigator Affiliation:

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


China: Food and Drug Administration

Study ID:




Start Date:

February 2007

Completion Date:

February 2012

Related Keywords:

  • Hepatocellular Carcinoma
  • Hepatocellular Carcinoma
  • Thymopentin
  • Recurrence
  • Resection
  • Carcinoma
  • Carcinoma, Hepatocellular