Immuno-effect of Tα1 for Stage I NSCLC (NCT06598839) | Clinical Trial Compass
RecruitingNot Applicable
Immuno-effect of Tα1 for Stage I NSCLC
China40 participantsStarted 2024-06-30
Plain-language 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).
Who can participate
Age range18 Years – 75 Years
SexALL
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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