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Trial · Interventional

CompletedPhase 2Registry data

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

NCTNCT03659578 (opens ClinicalTrials.gov in a new tab)Other idGASTO-1043
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
69 participants (actual)
Sponsor
Sun Yat-sen University · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

China

Start
9 Aug 2018
Primary completion
30 Sept 2021
Completion
30 Sept 2021
First posted
6 Sept 2018
Last update posted
3 Jan 2022
Conditions
Non-small Cell Lung Cancer

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20182019202020212022
  1. Ph 2

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

    NCT03659578

    9 Aug 2018 to 30 Sept 2021

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Concurrent chemotherapyDrug
  • split-course radiotherapyRadiation
  • thymosin alpha 1Drug

Arms1

  • Experimental

    Thymosin α1

    Patients are 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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Incidence of ≥grade 2 radiation pneumonitis (CTCAE 5.0 version)

    Time frame · 1-year

    Registry description

    Radiation-induced pneumonitis except other reasons induced pneumonia

Secondary outcomes(3)

  1. Total lymphocyte count

    Time frame · From the beginning of CCRT until 6 months after the completion of CCRT.

  2. C-reaction protein

    Time frame · From the beginning of CCRT until 6 months after the completion of CCRT.

  3. grade of pulmonary fibrosis (CTCAE 5.0 version)

    Time frame · 1-year

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies3

Studies that cite this trial.

Studies with results

3 studies on this page

Indexing hint: Randomized controlled trial · 2013

4 results

The efficacy of thymosin alpha 1 for severe sepsis (ETASS): a multicenter, single-blind, randomized and controlled trial.

Wu et al. 2013Critical care (London, England)cited by 105

PMID 23327199PMC4056079DOI 10.1186/cc11932PUB-23327199

CC BY4 results
Download PDFSee results (4)

Indexing hint: Randomized controlled trial · 2008

4 results

[The prophylactic effect of thymosin alpha 1 on the acute exacerbation of chronic obstructive pulmonary disease].

Zheng et al. 2008Sichuan da xue xue bao. Yi xue ban = Journal of Sichuan University. Medical science editioncited by 4

PMID 18798500PUB-18798500

Full text at the publisher4 results
Publisher pageSee results (4)

Indexing hint: Animal study · 2004

7 results

Thymosin alpha 1 activates dendritic cells for antifungal Th1 resistance through toll-like receptor signaling.

Romani et al. 2004Bloodcited by 164

PMID 14982877DOI 10.1182/blood-2003-11-4036PUB-14982877

Rights unknown7 results
Source linkSee results (7)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Pathologic confirmation of NSCLC. * Patients have measurable or evaluable lesions based on the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. * Unresectable phase IIIA-IIIC lung cancer confirmed by PET/CT, CT or MRI. * Whole lung V20\>=35% when giving 60Gy which is the minimum dose of radical irradiation. * Eastern Cooperative Oncology Group (ECOG) performance status 0-1. * Previously treated with chemotherapy or treatment-naive * No previous chest radiotherapy, immunotherapy or biotherapy * Hemoglobin≥10 mg/dL, platelet≥100000/μL,absolute neutrophil count ≥1500/μL * Serum creatinine ≤1.25 times the upper normal limit(UNL), or creatinine clearance≥60 ml/min * Bilirubin ≤1.5 times UNL, AST（SGOT）≤2.5 times UNL ,ALT（SGPT）≤2.5 times UNL,alkaline phosphatase ≤5 times UNL * FEV1 \>0.8 L * CB6 within normal limits * patients and their family signed the informed consents Exclusion Criteria: * Previous or recent another malignancy, except nonmelanoma skin cancer or cervical cancer in situ * Contraindication for chemotherapy * Malignant pleural or pericardial effusion. * Women in pregnancy, lactation period, or no pregnancy test 14 days before the first dose * Women who has the probability of pregnancy without contraception * Tendency of hemorrhage * In other clinical trials within 30 days * Addicted in drugs or alcohol, AIDS patients * Uncontrollable seizure or psychotic patients without self-control ability * Severe allergy or idiosyncrasy * Not suitable for this study judged by researchers

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