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Trial · Interventional

Status unknownPhase 2Registry data

Thymalfasin-based PRaG Mode for Advanced Refractory Solid Tumors

Overview

Status
Status unknown
Phase
Phase 2
Enrollment
60 participants (estimated)
Sponsor
Second Affiliated Hospital of Soochow University · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

China

Start
1 Apr 2023 (estimated)
Primary completion
May 2025 (estimated)
Completion
Dec 2025 (estimated)
First posted
30 Mar 2023
Last update posted
30 Mar 2023
Conditions
Advanced Solid Tumor · Refractory Tumor

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2023202420252026
  1. Ph 2

    Thymalfasin-based PRaG Mode for Advanced Refractory Solid Tumors

    NCT05790447

    est. 1 Apr 2023 to est. Dec 2025

Registry summary

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

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.

Interventions

  • ThymalfasinDrug
  • RadiotherapyRadiation
  • PD-1/PD-L1 inhibitorDrug
  • GM-CSFDrug

Arms1

  • Experimental

    Intervention group

    A treatment 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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Overall response rate (ORR)

    Time frame · 24 months

    Registry 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.

Secondary outcomes(4)
  1. Disease control rate (DCR)

    Time frame · 24 months

    Registry description

    the percentage of patients who have achieved complete response (CR), partial response (PR) and stable disease (SD)

  2. Progression free survival (PFS)

    Time frame · 24 months

    Registry description

    The time from commencement of treatment to disease progression or death from any cause.

  3. Overall survival (OS)

    Time frame · 24 months

    Registry description

    The time from the first day of enrollment to death from any cause.

  4. Incidence of adverse events

    Time frame · 24 months

    Registry description

    the rate of AE

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.

A trial that is still running, or that stopped early, may post results later.

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

Studies4

Studies that cite this trial.

Studies with results

3 studies on this page

PubMed tag: none · 2024

Evaluation of the efficacy and safety of a precise thymalfasin-regulated PRaG regimen for advanced refractory solid tumours: protocol for the open-label, prospective, multicentre study (PRaG5.0 study).

Kong et al. 2024BMJ opencited by 4

PMID 38458816PMC10928769DOI 10.1136/bmjopen-2023-075642PUB-38458816

Free to read · publisher termsCC BY-NC
Read at source

Indexing hint: Clinical trial · 2022

6 results

Efficacy of Thymosin α1 in Management of Radiation Pneumonitis in Patients With Locally Advanced Non-Small Cell Lung Cancer Treated With Concurrent Chemoradiotherapy: A Phase 2 Clinical Trial (GASTO-1043).

Liu et al. 2022International journal of radiation oncology, biology, physicscited by 26

PMID 35870709DOI 10.1016/j.ijrobp.2022.07.009PUB-35870709

Full text at the publisher6 results

Indexing hint: In vitro study · 2015

5 results

Dual effect of Thymosin α 1 on human monocyte-derived dendritic cell in vitro stimulated with viral and bacterial toll-like receptor agonists.

Giacomini et al. 2015Expert opinion on biological therapycited by 19

PMID 26096650DOI 10.1517/14712598.2015.1019460PUB-26096650

Rights unknown5 results

Indexing hint: Randomized controlled trial · 1985

4 results

A randomized trial to evaluate the immunorestorative properties of synthetic thymosin-alpha 1 in patients with lung cancer.

Schulof et al. 1985Journal of biological response modifierscited by 36

PMID 3998766PUB-03998766

Full text at the publisher4 results

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultKong Y, Zhao X, Xu M, Pan J, Ma Y, Zou L, Peng Q, Zhang J, Su C, Xu Z, Zhou W, Peng Y, Yang J, Zhou C, Li Y, Guo Q, Chen G, Wu H, Xing P, Zhang L. PD-1 Inhibitor Combined With Radiotherapy and GM-CSF (PRaG) in Patients With Metastatic Solid Tumors: An Open-Label Phase II Study. Front Immunol. 2022 Jul 8;13:952066. doi: 10.3389/fimmu.2022.952066. eCollection 2022. PMID 35874780

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. Subjects aged≥ 18 years; 2. Enrolled subjects who shall meet the criteria of recurrent or metastatic advanced solid malignant tumors, have a definite pathology diagnosis report or medical history, without definitely recommended standard treatment regimen in the guidelines, and cannot tolerate or are unwilling to receive the standard treatment regimen, and have clear, measurable metastatic lesions (\>1cm); 3. Subjects who have not suffered from congestive heart failure, unstable angina, or unstable arrhythmia in the past 6 months; 4. Subjects who have the ECOG (Eastern Cooperative Oncology Group) performance status score of 0-3 and the life expectancy≥3 months; 5. Subjects who have no serious abnormalities of hematopoietic functions, heart, lung, liver, kidney functions, or immune deficiency in the past; 6. Subjects whose AST and ALT levels are ≤3.0 times the upper limit of normal (≤5.0 times the upper limit of normal for patients with liver cancer/metastasis liver carcinoma), and creatinine level is ≤3.0 times the upper limit of normal one week before enrollment. 7. Subjects who shall have the ability to understand and voluntarily sign the informed consent forms. Exclusion Criteria: 1. Pregnant or lactating women. 2. Subjects who have a history of other malignant diseases in the last 5 years, expect for:malignancies that can be cured after treatment (including but not limited to adequately treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell skin cancer). 3. Subjects who have a history of uncontrolled epilepsy, CNS disease or mental disorder. 4. Subjects with clinically severe (active) cardiac disease such as symptomatic coronary heart disease, NYHA Class II or worse congestive heart failure, or severe arrhythmias requiring medical intervention, or a history of myocardial infarction within the last 12 months. 5. Subjects who require immunosuppressive therapy for organ transplantation. 6. Subjects with known significant active infection or significant disorders of blood, kidney, metabolism, gastrointestinal, endocrine functions or metabolisms as judged by the Investigator, or other severe, uncontrolled concomitant diseases. 7. Subjects who are allergic to any ingredient of the investigational drug. 8. Subjects who have a medical history of immunodeficiency, including HIV-positive or other acquired or congenital immunodeficiency diseases, or those with a history of organ transplantation, or those with other immune-related diseases requiring long-term oral hormone therapy. 9. Subjects who are in the stage of acute and chronic tuberculosis infections (positive result of T-spot test, with suspected tuberculous lesions on chest X-ray). 10. Other conditions that are not suitable for enrollment in the Investigator's opinions.

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