Recruiting NCT06598839
Immuno-effect of Tα1 for Stage I NSCLC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Thymosin Alpha1.
- Who it may be relevant to
- Registry conditions: Non Small Cell Lung Cancer. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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 Thymosin Alpha1
subcutaneous injection of Tα1, 1.6mg each time, biw, for 3 months
Primary outcome measures
- Number of CTCs [Time frame: 4 months after sugery]
Secondary outcome measures (3)
- Number of immune cells [Time frame: 4 months after sugery]
- Peripheral blood immune cells profile [Time frame: 4 months after sugery]
- AE [Time frame: within 4 months after sugery]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chine — Beijing
Identifiers
NCT: NCT06598839 · NCC4407 · NCC4407