Thymalfasin Adjuvant Therapy in Hepatitis B Virus (HBV)-Related Hepatocellular Carcinoma (HCC) After Curative Resection

What Was Tested

In this phase 4 trial, researchers set out to test Thymosin Alpha-1.

It had two arms (groups): treatment (T) (experimental) and control (C) (other).

The patients of control arm will be followed up for 2 years periodically after curative resection, without the investigational product (Thymalfasin) therapy. Nucleoside analog plan to give to HBV DNA positive patients.

The registry classes the interventions as drug and procedure.

Who Took Part

360 planned participants were the target.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Male or female patients with age between 18-70 years. Life expectance ≥ 3 months. Diagnosis of Hepatocellular Carcinoma confirmed by Histological or Cytological examination. Hepatitis B history with current HBsAg positive and/or HBV DNA positive. Will undergo hepatic curative resection.

The full record lists 12 inclusion and 18 exclusion criteria; among the exclusions: taking the hepatotoxic drug or immunosuppressant drug; organ transplant recipient; extra-hepatic organs and lymph node metastasis.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

The participants were allocated by chance, so the Thymosin Alpha-1 group and the comparison group should start out alike.

The Thymosin Alpha-1 group and the comparison group ran side by side rather than switching.

Everyone knew when Thymosin Alpha-1 was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2015-01 with completion listed for 2018-06.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Recurrence-free Survival (time frame: 2-year).

It also tracked 7 secondary outcomes, for example Recurrence-free Survival (RFS), Overall survival (OS), Overall survival (OS), Mean recurrence time, Tumor sample immune cell counts and incidence and types of Adverse Events (AE) and serious adverse event (SAE).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Thymosin Alpha-1 in 360 people.

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

More context: the Thymosin Alpha-1 compound page, all human trials.