Efficacy and Safety of Anti-PD-1, Thymalfasin, and SOX in Neoadjuvant Treatment of cStage III Gastric/Gastroesophageal Junction Adenocarcinoma

What Was Tested

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

It had 1 arm (groups): Serplulimab Combined with Thymalfasin and SOX (experimental).

The registry classes the interventions as drug.

More on the Plan

It is planned to enroll 30 patients with HER2-negative gastric or gastroesophageal junction adenocarcinoma confirmed by histopathology and/or cytology who were clinically staged as stage III resectable G/GEJ carcinoma as assessed by endoscopic ultrasonography, CT/MRI and other imaging.

The primary endpoint of the study was pathological complete response (pCR) rate.

The secondary end points included major pathological response(MPR) rate, Tumor Regression Grade (TRG), Clinical downstaging rate (T and/or N downstaging), Objective Response Rate (ORR), Disease Control Rate (DCR), R0 resection rate, Disease-free Survival (DFS), Overall Survival (OS) and treatment-related adverse events (TRAEs).

Who Took Part

30 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: Age and Diagnosis:. Stage and Diagnosis Confirmation:.

The full record lists 13 inclusion and 1 exclusion criteria; among the exclusions: other malignancies:.

How the Study Was Run

Design: 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 2024-06-14 with completion listed for 2026-01-28.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: pathological Complete Response (pCR) (time frame: from preoperative to 10 days postoperative).

It also tracked 9 secondary outcomes, for example Major Pathological Response (MPR), Tumor Regression Grade (TRG), Clinical downstaging rate (T and/or N downstaging), Objective Response Rate (ORR), Disease Control Rate (DCR) and Disease-free Survival (DFS).

What This Means in Plain Language

Put simply, this is a phase 2 trial of Thymosin Alpha-1 in 30 people.

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

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.