SBRT Combined With Thymalfasin for Metastatic Esophageal Cancer

What Was Tested

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

It had 1 arm (groups): SBRT and Thymalfasin arm (experimental).

SBRT is given during combined therapy to one of the lesions, 25Gy in 5 fractions over one week, conformally to maximally spare normal tissue or organ. Thymalfasin treatment is given twice a week with an interval of 3-4 days until tumor progression of other metastatic lesions. Tumor response is evaluated by assessing clinical and CT/MRI response for all the other measurable metastatic sites.

The registry classes the interventions as drug and radiation.

More on the Plan

Extent of metastatic disease is recorded both at CT and PET/CT scanning.

Radiation is given during combined therapy to one of the lesions, 25Gy in 5 fractions over one week interval with SBRT, conformally to maximally spare normal tissue or organ.

Thymalfasin treatment is given twice a week with an interval of 3-4 days each week for a total of 8 weeks.

Tumor response is evaluated by assessing clinical and CT/MRI response for all of the measurable metastatic sites.

Who Took Part

29 planned participants were the target.

It was open to people of any sex aged from 19 years with no upper age limit.

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

Examples of who could join: Patients must have at least 2 distinct measurable metastatic sites at least 1 cm of larger in their largest diameter;. Age ≥18 years;. ECOG performance status: 0-1;. Life expectancy ≥ 3 months. Signed consent forms voluntarily;.

The full record lists 8 inclusion and 9 exclusion criteria; among the exclusions: patients undergoing therapy with other investigational agents; women who are pregnant or breastfeeding;; patients with known brain metastases can be included in this clinical trial but brain lesions are not eligible as target or non target lesion;.

How the Study Was Run

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

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.

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

It started in 2016-01 with completion listed for 2017-12.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): The proportion of patients with tumor responses after the initiation of treatment (time frame: month 1- month 6).

It also tracked 2 secondary outcomes, for example The number of participants with adverse events from the date of enrollment until 2 years from the opening of the study.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Thymosin Alpha-1 in 29 people.

Its size is small, so on its own it can only give an early look.

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.