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Clinical Trials in China / NCT06598839
Recruiting Not applicable

Immuno-effect of Tα1 for Stage I NSCLC

NCT06598839 · tracked via the Priya Life Science China tracker
Sponsor
Yousheng Mao
Phase
Not applicable
Started
2024-06-30
Last updated
2024-09-19

Condition(s) studied

Non Small Cell Lung Cancer

Investigational drug(s) / intervention(s)

Thymosin Alpha1 →

Thymosin Alpha1: subcutaneous injection of Tα1, 1.6mg each time, biw, for 3 months

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

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

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06598839 on ClinicalTrials.gov ↗ ← All trials in China