Immuno-effect of Tα1 for Stage I NSCLC

September 12, 2024 updated by: Yousheng Mao

Assessment of the Efficacy of Immunomodulatory Therapy With Thymosin Alpha 1 (Tα1) Following Surgical Resection in Patients With Stage I Non-Small Cell Lung Cancer

To explore the effect of thymosin alpha 1 (Tα1) on postoperative peripheral blood circulating tumor cells and immunosenescence in patients with early-stage non-small cell lung cancer (NSCLC).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100021
        • Recruiting
        • National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Pathologically confirmed stage I (per AJCC 8th edition) invasive NSCLC
  • Resectable tumor
  • undergoing lobectomy and systemic lymph node dessection
  • Without a previous history of malignant tumors or other concurrent malignancies
  • Naïve to any anticancer therapies or other immunostimulatory agents
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) score 0-1, with cardiac, pulmonary, hepatic, cerebral, and renal functions capable of withstanding surgery
  • Aged ≥18 years and ≤75 years
  • Having signed written informed consent and capable of adhering to the visit schedule and related procedures outlined in the study protocol

Exclusion Criteria:

  • With a pathologically confirmed non-invasive NSCLC, including preinvasive lesions, small cell lung cancer, and benign lesions
  • Post-diagnostic use of immunosuppressive medications or other immunostimulatory agents
  • With known or suspected active autoimmune disease
  • Allergic to thymopeptides
  • With other uncontrolled serious illnesses or having acute or chronic conditions that may confound test outcomes, including active severe clinical infections ( >NCI-CTCAE grade 2 infection); diagnosed with epilepsy requiring antiepileptic treatment; on renal dialysis; with non-healing wounds, ulcers, or fractures; with a history of arteriovenous thrombotic events, including cerebrovascular accident, deep vein thrombosis, and pulmonary embolism, within six months prior to the first dose

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
only observation after surgery
Experimental: Tα1 group
Tα1 treatment for 3 months after surgery
Drug: Thymosin Alpha1
subcutaneous injection of Tα1, 1.6mg each time, biw, for 3 months
Other Names:
  • Thymalfasin
  • Tα1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of CTCs
Time Frame: 4 months after sugery
Number of peripheral blood circulating tumor cells after Tα1 treatment
4 months after sugery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of immune cells
Time Frame: 4 months after sugery
Number of TERT+ immnue cells after Tα1 treatment
4 months after sugery
Peripheral blood immune cells profile
Time Frame: 4 months after sugery
Number of immune cells profile, including but limited to CD4+, CD8+, T cells
4 months after sugery
AE
Time Frame: within 4 months after sugery
the safety profile of the Tα1 treatment
within 4 months after sugery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yousheng Mao

Investigators

  • Principal Investigator: Yousheng Mao, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2024

Primary Completion (Estimated)

September 30, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

September 12, 2024

First Submitted That Met QC Criteria

September 12, 2024

First Posted (Estimated)

September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 12, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCC4407 (Other Identifier: national cancer center)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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