Thymosin-alpha 1 for Adjuvant Treatment After Radical Resection of High-risk Stage II and III Colorectal Cancer

What Was Tested

This registered phase 3 trial tested Thymosin Alpha-1.

This study hopes to verify the effecacy and safety of thymosin-alpha 1 for adjuvant treatment of high-risk stage II and stage III colorectal cancer after radical resection.

It had two arms (groups): Thymosin (experimental) and Observe (no intervention).

Patients with pathological high-risk stage II and stage III colorectal cancer after radical resection.

Patients with pathological high-risk stage II and stage III colorectal cancer after radical resection.

The registry classes the interventions as drug.

More on the Plan

Patients with pathological high-risk stage II and stage III colorectal cancer after radical resection were randomly allocated to receive thymosin-alpha 1 twice a week for 6 months (experimental group) or not (control group) in a 1:1 ratio.

At the same time, all patients will receive chemo/radiotherapy according to the Chinese Standards for Diagnosis and Treatment of Colorectal Cancer.

The primary endpoint is 3-year DFS rate.

Who Took Part

Enrollment: 2500 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: Colorectal cancer receiving radical resection. Pathologically diagnosed with high-risk stage II or stage III. Eastern Cooperative Oncology Group performance status of 0-2. Adequate hepatic, renal, and hematologic function.

The full record lists 4 inclusion and 2 exclusion criteria; among the exclusions: had previously taken any immune-promoting drugs; pregnancy or lactation.

How the Study Was Run

It was run as a randomized, parallel-group and single-blind study.

Because people in this Thymosin Alpha-1 study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Only one side, usually the participants, was kept unaware of whether Thymosin Alpha-1 was given.

Those kept unaware of assignments: outcomes assessor.

It started in 2021-04-01 with completion listed for 2027-03-31.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: 3-year disease-free survival rate (time frame: 3 years).

It also tracked 2 secondary outcomes, for example 3-year overall survival rate and rate of adverse events related to thymosin-alpha 1.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Thymosin Alpha-1 in 2500 people.

With 2500 participants it is a large trial for this field.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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