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

What Was Tested

This registered phase 3 trial tested Thymopentin.

The registry classes the interventions as drug.

More on the Plan

However, these approaches are either controversial or require further evaluation , a substantial need for novel treatments is required urgently.

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) .

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.

Who Took Part

220 planned participants were the target.

It was open to people of any sex aged from 18 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Patients who received curative resection of HBV-related small HCC (pathologically proved, solitary tumour \<5cm, or two/ tumours \<5cm). 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.

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: history of cardiac disease; active clinically serious infection; known history of human immunodeficiency virus (hiv) infection.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Because people in this Thymopentin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Thymopentin group and the comparison group ran side by side rather than switching.

Everyone knew when Thymopentin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2007-02 with completion listed for 2012-02.

It ran at 1 site in China.

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: disease-free survival (time frame: three year).

It also tracked 1 secondary outcome, for example overall survival.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Thymopentin in 220 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Thymopentin compound page, all human trials.