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Thymosin-alpha-1

Thymalfasin, Zadaxin, Thymosin α1

Quick Stats
Studies 759
Trials 63
Completed PHASE2 INTERVENTIONAL NCT03659578

Study of Thymosin α1 to Reduce Acute Pneumonia For Bulky None-small Cell Lung Cancer

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

This Phase II study is to determine the efficacy of Thymosin α1 on the frequency of acute pneumonia in non-small cell lung cancer with bulky tumor.

Detailed Description

This Phase II study is to determine the efficacy of Thymosin α1 on the frequency of radiation pneumonitis in non-small cell lung cancer with bulky tumor. All patients received four cycles of weekly docetaxel (25mg/㎡) and nedaplatin (25mg/㎡)(DP), each of 1 day's duration, combined with split-course thoracic radiotherapy of 51 Gy in 17 fractions or 40 Gy in 10 fractions as the first course followed by a break of four weeks. Patients without disease progression had a dose of 15 Gy in 5 fractions or 24 Gy in 6 fractions as a boost. Patients were further treated with subcutaneous injections of thymosin once a week,1.6mg each time from the start of radiation to 2 months after the end of radiation. Toxicities will be graded according to CTCAE v. 4.0.

Interventions

Name: Concurrent chemotherapy
Type: DRUG
Description: Concurrent chemotherapy consists of weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡), each of 1 day's duration.
Name: split-course radiotherapy
Type: RADIATION
Description: Patient was administered with 51 Gy in 17 fractions or 40 Gy in 10 fractions as the first course followed by a break of four weeks. Patients without disease progression had a dose of 15 Gy in 5 fractions or 24 Gy in 6 fractions as a boost
Name: thymosin alpha 1
Type: DRUG
Description: subcutaneous injections of thymosin once a week,1.6mg each time from the start of radiation to 2 months after the end of radiation.

Primary Outcomes

Measure: Incidence of ≥grade 2 radiation pneumonitis (CTCAE 5.0 version)
TimeFrame: 1-year
Description: Radiation-induced pneumonitis except other reasons induced pneumonia

Trial Information

NCT ID

NCT03659578

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE2

Sponsor

Sun Yat-sen University

Last Updated

December 15, 2025