Radiotherapy With Sequential Chemotherapy Combined With PD-1 Inhibitor and Thymalfasin for BRPC

What Was Tested

This registered phase 2 trial tested Thymosin Alpha-1.

This is a prospective, single-center, single-arm, phase II clinical study.

It had 1 arm (groups): CRT+PD-1 inhibitor+Thymalfasin (experimental).

All eligible 20 subjects will receive a neoadjuvant therapy regimen of chemoradiotherapy combined with anti-PD-1 monoclonal antibody and Thymalfasin.

The registry classes the interventions as combination product.

More on the Plan

In this study, 20 patients with borderline resectable pancreatic cancer and without any prior treatment will be enrolled.

The postoperative treatment of patients will be jointly decided by clinical physicians and patients according to the actual conditions of clinical diagnosis and treatment.

Who Took Part

Enrollment: 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: Age ≥ 18 years, with ECOG score of 0 \~ 1;. Histologically or cytologically confirmed diagnosis of ductal adenocarcinoma of pancreas;. Classification as borderline resectable pancreatic cancer according to the NCCN Guidelines (2024 Edition);. Deemed suitable for neoadjuvant therapy following discussion by the MDT team of the study site;. Subjects must meet the following criteria for hematology test:.

The full record lists 16 inclusion and 15 exclusion criteria; among the exclusions: prior systemic anti-tumor therapy;; prior history of abdominal radiotherapy;; subjects with active bacterial or fungal infection (≥ grade 2 as per nci-ctc, version 3).

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 2024-09-01 with completion listed for 2025-09-01.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: R0 resection rate (time frame: within 10 days after surgery).

It also tracked 10 secondary outcomes, for example Tumor regression grade (TRG), Pathologic complete response (pCR) rate, Median progression-free survival (mPFS), Median overall survival (mOS), Major pathologic response (MPR) rate and Objective response rate (ORR).

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 not yet 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.