Immuno-effect of Tα1 for Stage I NSCLC

NCT06598839 | Recruiting

• 1 other identifier: NCC4407
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Non Small Cell Lung Cancer

Keywords

NSCLC; Thymosin alpha1; CTC; Immunosenescence

Outcome Measures

Primary Outcomes (1)

• Number of CTCs

  Number of peripheral blood circulating tumor cells after Tα1 treatment

  4 months after sugery

Secondary Outcomes (3)

• Number of immune cells

  4 months after sugery

• Peripheral blood immune cells profile

  4 months after sugery

• AE

  within 4 months after sugery

Study Arms (2)

Control group

NO INTERVENTION

only observation after surgery

Tα1 group

EXPERIMENTAL

Tα1 treatment for 3 months after surgery

Drug: Thymosin Alpha1

Interventions

Thymosin Alpha1 DRUG

subcutaneous injection of Tα1, 1.6mg each time, biw, for 3 months

Also known as: Tα1, Thymalfasin

Tα1 group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yousheng Mao: lead

Study Sites (1)

National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Thymalfasin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Thymosin; Thymus Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins; Proteins

Study Officials

• Yousheng Mao

  National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yousheng Mao

CONTACT

8610-67781331; youshengmao@gmail.com

Li Fu

CONTACT

fulipumc@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: September 19, 2024
• Study Start: June 30, 2024
• Primary Completion: September 30, 2025
• Study Completion: December 30, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)