DRUG
Thymosin Alpha1
subcutaneous injection of Tα1, 1.6mg each time, biw, for 3 months
Status
Recruiting
Phase
Not applicable
Enrollment
40
Locations
1
Results
Not posted
Publications
0
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).
Interventions
DRUG
subcutaneous injection of Tα1, 1.6mg each time, biw, for 3 months
Timeline
First posted
Sep 19, 2024
Study start
Jun 30, 2024
Primary completion
Sep 30, 2025
Study completion
Dec 30, 2025
Results posted
Not reported
Registry updated
Sep 19, 2024
Outcomes
Number of CTCs
Time frame · 4 months after sugery
Number of peripheral blood circulating tumor cells after Tα1 treatment
Number of immune cells
Time frame · 4 months after sugery
Number of TERT+ immnue cells after Tα1 treatment
Peripheral blood immune cells profile
Time frame · 4 months after sugery
Number of immune cells profile, including but limited to CD4+, CD8+, T cells
AE
Time frame · within 4 months after sugery
the safety profile of the Tα1 treatment
Eligibility
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 locations
China. Showing up to 24 locations stored in the fast local snapshot.
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China
Publications
No PMID-linked publications were present in this registry snapshot.
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Related PeptideStat pages
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