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Thymosin-alpha-1

Thymalfasin, Zadaxin, Thymosin α1

Quick Stats
Studies 759
Trials 63
Recruiting PHASE2 INTERVENTIONAL NCT05790447

Thymalfasin-based PRaG Mode for Advanced Refractory Solid Tumors

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

This is an open-label, single-arm, Phase II investigator-initiated trial of precise thymalfasin-regulated therapy combined with hypofractionated radiotherapy, PD-1/PD-L1 inhibitor sequential GM-CSF for treatment of advanced refractory solid tumors.

Detailed Description

One cycle of activation cycle includes: Loading dose with thymalfasin was administrated based on the absolute number of T lymphocytes. Radiotherapy (5 or 8Gy three fractions)was administrated to a metastatic lesion. GM-CSF 200ug was subcutaneous injected for seven days from the first day of radiotherapy PD-1/L1 inhibitor was intravenous injected within one week after radiotherapy. At least two activation cycles were administrated. Then maintenance treatment includes: Loading dose with thymalfasin was administrated based on the absolute number of T lymphocytes. GM-CSF 200ug was subcutaneous injected for seven days. PD-1/L1 inhibitor was intravenous injected.

Interventions

Name: Thymalfasin
Type: DRUG
Description: loading dose with thymalfasin based on the amounts of T lymphocyte
Name: Radiotherapy
Type: RADIATION
Description: hypofractionated radiotherapy/SBRT
Name: PD-1/PD-L1 inhibitor
Type: DRUG
Description: The PD-1/PD-L1 inhibitors are used within one week after radiotherapy
Name: GM-CSF
Type: DRUG
Description: subcutaneous injection daily for 7 consecutive days

Primary Outcomes

Measure: Overall response rate (ORR)
TimeFrame: 24 months
Description: ORR is defined as the proportion of patients who have a partial (PR) or complete response (CR) to therapy among the total number of evaluable patients.

Trial Information

NCT ID

NCT05790447

Status

Recruiting

Study Type

INTERVENTIONAL

Phases

PHASE2

Sponsor

Second Affiliated Hospital of Soochow University

Last Updated

December 15, 2025