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Trial Title:
Immuno-effect of Tα1 for Stage I NSCLC
NCT ID:
NCT06598839
Condition:
Non Small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Thymalfasin
Conditions: Keywords:
NSCLC
Thymosin alpha1
CTC
Immunosenescence
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Thymosin Alpha1
Description:
subcutaneous injection of Tα1, 1.6mg each time, biw, for 3 months
Arm group label:
Tα1 group
Other name:
Tα1
Other name:
Thymalfasin
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).
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Address:
City:
Beijing
Zip:
100021
Country:
China
Status:
Recruiting
Contact:
Last name:
Yousheng Mao
Phone:
+86-010-67781331
Email:
youshengmao@gmail.com
Start date:
June 30, 2024
Completion date:
December 30, 2025
Lead sponsor:
Agency:
Yousheng Mao
Agency class:
Other
Source:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06598839
