"Thymalfasin Immunotherapy Study with Triple Regimen in Advanced MSS/pMMR Colorectal Cancer"

What Was Tested

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

This is a multicenter, open-label, prospective, randomized controlled Phase II clinical study.

All eligible subjects will be randomly assigned in a 1:1 ratio to either the triple therapy group or the double therapy group.

Triple therapy group: Subjects will receive Thymalfasin in combination with Regorafenib and Tislelizumab until iCPD is achieved per iRECIST (progressive disease (PD) per iRECIST), or until an intolerable toxicity occurs; Double therapy group: Subjects will receive Regorafenib and Tislelizumab until iCPD is achieved per iRECIST (PD per iRECIST), or until an intolerable toxicity occurs.

It had two arms (groups): Triple therapy group (experimental) and Double therapy group (active comparator).

Subjects will receive Thymalfasin in combination with Regorafenib and Tislelizumab.

Subjects will receive Regorafenib and Tislelizumab.

The registry classes the interventions as drug.

More on the Plan

Within a 9-month enrollment period and a total study duration of 15 months, 44 subjects need to be enrolled to achieve this.

Allocation of enrollment across sites: Each site will compete for enrollment, with each site enrolling no less than 14 subjects. 1.

Who Took Part

52 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.

The full record lists 1 inclusion and 1 exclusion criteria.

How the Study Was Run

Design: 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 2025-02-11 with completion listed for 2025-12-31.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Progression-free survival (PFS) (time frame: 48 WEEKS).

It also tracked 5 secondary outcomes, for example 18-week PFS rate, Objective response rate (ORR), Disease control rate (DCR), Overall survival (OS) and 1-year OS rate.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Thymosin Alpha-1 in 52 people.

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.