Thymosin Alpha-1 for irAE Secondary to ICIs

What Was Tested

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

Therefore, this study is attempted to explore whether Tα-1 could be used as a therapeutic option for the treatment of immune-related adverse events (irAEs).

It had two arms (groups): Tα-1 group (experimental) and Control group (active comparator).

Conventional therapy includes corticosteroids and other immunosuppressants according to CSCO guidelines.

The registry classes the interventions as drug.

Who Took Part

40 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: Subjects who are males or females, aged 18 to 75 years;. Subjects who are willing to sign the informed consent forms and receive follow-up visits;. Subjects who are cytologically or histologically diagnosed with malignant solid tumors, including but not limited to genitourinary, gynecological, lung, liver, gastrointestinal tumors and melanoma;. Subjects with Grade 2 to 4 skin toxicity, enteritis, pneumonia and hepatitis secondary to ICIs according to CTCAE V5.0 and CSCO guidelines. Subjects with sufficient bone marrow functions and meet the following requirements:.

The full record lists 6 inclusion and 14 exclusion criteria; among the exclusions: subjects who have ever immune-related adverse events due to ici treatment;; subjects who are diagnosed with immunodeficiency disease or are receiving systemic immunosuppressive therapy;; subjects who have skin damage, liver damage, lung damage, etc. caused by the progression of malignant tumors;.

How the Study Was Run

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

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

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

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 2023-09-01 with completion listed for 2024-11.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Symptoms relieving rate (time frame: within one week after the first injection of thymalfasin).

It also tracked 3 secondary outcomes, for example ≤G1 rate and Median relieving time.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Thymosin Alpha-1 in 40 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.