Status:
RECRUITING
Immuno-effect of Tα1 for Stage I NSCLC
Lead Sponsor:
Yousheng Mao
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
NA
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).
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06598839
Start Date
June 30 2024
End Date
December 30 2025
Last Update
September 19 2024
Active Locations (1)
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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, China, 100021