Thymalfasin-based PRaG Mode for Advanced Refractory Solid Tumors

What Was Tested

In this phase 2 trial, researchers set out to test Thymosin Alpha-1.

This is an open-label, single-arm, Phase II investigator-initiated trial of precise thymalfasin-regulated therapy combined with hypofractionated radiotherapy, PD-1/PD-L1 inhibitor sequential GM-CSF for treatment of advanced refractory solid tumors.

It had 1 arm (groups): Intervention group (experimental).

The registry classes the interventions as drug and radiation.

More on the Plan

Radiotherapy (5 or 8Gy three fractions)was administrated to a metastatic lesion.

At least two activation cycles were administrated.

PD-1/L1 inhibitor was intravenous injected.

Who Took Part

The registry lists 60 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Subjects aged≥ 18 years;. Subjects who have not suffered from congestive heart failure, unstable angina, or unstable arrhythmia in the past 6 months;. Subjects who have the ECOG (Eastern Cooperative Oncology Group) performance status score of 0-3 and the life expectancy≥3 months;. Subjects who have no serious abnormalities of hematopoietic functions, heart, lung, liver, kidney functions, or immune deficiency in the past;. Subjects who shall have the ability to understand and voluntarily sign the informed consent forms.

The full record lists 7 inclusion and 10 exclusion criteria; among the exclusions: pregnant or lactating women; subjects who have a history of uncontrolled epilepsy, cns disease or mental disorder; subjects who require immunosuppressive therapy for organ transplantation.

How the Study Was Run

The set-up was single-group and open-label.

Nothing was hidden in this open-label Thymosin Alpha-1 study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2023-04-01 with completion listed for 2025-05.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Overall response rate (ORR) (time frame: 24 months).

It also tracked 4 secondary outcomes, for example Disease control rate (DCR), Progression free survival (PFS), Overall survival (OS) and Incidence of adverse events.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Thymosin Alpha-1 in 60 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.