Neoadjuvant Chemoradiotherapy Combined With PD-1 Inhibitor and Thymalfasin for pMMR/MSS Locally Advanced Mid-low Rectal Cancer

What Was Tested

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

It had 1 arm (groups): cCRT+tislelizumab+thymalfasin (experimental).

A total of 20 pMMR/MSS locally advanced middle and low rectal cancer patients will receive long-course concurrent chemoradiotherapy combined with 3 cycles of tislelizumab and 11 weeks of thymalfasin therapy.

The registry classes the interventions as drug and radiation.

More on the Plan

This study is an open, prospective, multi-center, single-arm phase II clinical study.

In this study, patients with pMMR/MSS locally advanced middle and low rectal cancer were selected as the subjects and treated with neoadjuvant treatment protocol of long-course concurrent chemoradiotherapy combined with PD-1 monoclonal antibody and thymalfasin.

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

The secondary end points included treatment-related adverse events (TRAEs) rate, 30-day incidence of postoperative complications, objective response rate (ORR), 3-year disease-free survival (DFS) rate, Neoadjuvant rectal cancer (NAR) score, R0 resection rate, and anal preservation rate.

Who Took Part

The registry lists 20 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: Patients who were fully informed of the study and voluntarily signed the informed consent form;. Patients with rectal cancers must satisfied all the following conditions:.

The full record lists 2 inclusion and 22 exclusion criteria; among the exclusions: patients have a present or previous active malignancy except the diagnosis of rectal cancer this time;; patients underwent major surgery within 4 weeks prior to study treatment;; patients have any condition affects the absorption of capecitabine through gastrointestinal tract;.

How the Study Was Run

It was run as a single-group and open-label study.

Being open-label, the Thymosin Alpha-1 study did not mask who received what.

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

It started in 2024-01-03 with completion listed for 2024-12-01.

It ran at 2 sites in China (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: CR rate (time frame: from preoperative to 10 days postoperative).

It also tracked 7 secondary outcomes, for example TRAE, 30-day incidence of postoperative complications, ORR, 3-y DFS rate, NAR score and R0 resection rate.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Thymosin Alpha-1 in 20 people.

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

Its status is active not 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.