Effect of Thymosin Alpha1 on Early-Stage Lung Cancer
Assessment of the Efficacy of Immunomodulatory Therapy With Thymosin Alpha 1 (Tα1) Following Surgical Resection in Patients With Stage I Non-Small Cell Lung Cancer
This study is testing if a treatment called thymosin alpha 1 can help patients with early-stage lung cancer by reducing tumor cells in their blood and improving their immune response after surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06598839 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of thymosin alpha 1 (Tα1) on circulating tumor cells and immune aging in patients with stage I non-small cell lung cancer (NSCLC) following surgery. Participants will receive Tα1 treatment after undergoing lobectomy and lymph node dissection. The goal is to assess how this intervention may influence tumor cell presence in the bloodstream and the overall immune response in these patients. The study aims to provide insights into the potential immunological benefits of Tα1 in early-stage lung cancer management.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with pathologically confirmed stage I NSCLC who are undergoing surgical resection.
Not a fit: Patients with non-invasive NSCLC or those with active autoimmune diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance postoperative outcomes and immune function in patients with early-stage NSCLC.
How similar studies have performed: While the specific use of Tα1 in this context may be novel, similar immunotherapeutic approaches have shown promise in other cancer treatments.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Beijing, Beijing Municipality
- 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 (Recruiting)
Study contacts
- Principal investigator: Yousheng Mao — National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital
- Study coordinator: Yousheng Mao
- Email: youshengmao@gmail.com
- Phone: 8610-67781331
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.