Current partner codePEPTIDESDE
NCT06598839·Not applicable·INTERVENTIONAL

Immuno-effect of Tα1 for Stage I NSCLC

Status

Recruiting

Phase

Not applicable

Enrollment

40

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Treatment arms and agents.

DRUG

Thymosin Alpha1

subcutaneous injection of Tα1, 1.6mg each time, biw, for 3 months

Timeline

From registration to results.

  1. First posted

    Sep 19, 2024

  2. Study start

    Jun 30, 2024

  3. Primary completion

    Sep 30, 2025

  4. Study completion

    Dec 30, 2025

  5. Results posted

    Not reported

  6. Registry updated

    Sep 19, 2024

Outcomes

What the study measures.

Primary outcomes

Number of CTCs

Time frame · 4 months after sugery

Number of peripheral blood circulating tumor cells after Tα1 treatment

Secondary outcomes

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

Who can take part.

Minimum age
18 Years
Maximum age
75 Years
Sex
ALL
Healthy volunteers
No

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

1 registered sites.

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

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Thymosin Alpha-1.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.