Non Small Cell Lung Cancer
Conditions
Keywords
NSCLC, Thymosin alpha1, CTC, Immunosenescence
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).
Interventions
DRUGThymosin Alpha1
subcutaneous injection of Tα1, 1.6mg each time, biw, for 3 months
Sponsors
Yousheng Mao
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of CTCs | 4 months after sugery | Number of peripheral blood circulating tumor cells after Tα1 treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of immune cells | 4 months after sugery | Number of TERT+ immnue cells after Tα1 treatment |
| Peripheral blood immune cells profile | 4 months after sugery | Number of immune cells profile, including but limited to CD4+, CD8+, T cells |
| AE | within 4 months after sugery | the safety profile of the Tα1 treatment |
Countries
China
Contacts
Primary ContactYousheng Mao
Backup ContactLi Fu
Outcome results
None listed