Immuno-effect of Tα1 for Stage I NSCLC

NCT ID: NCT06598839

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-30

Study Completion Date

2025-12-30

Brief Summary

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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).

Detailed Description

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Conditions

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Non Small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control group

only observation after surgery

Group Type NO_INTERVENTION

No interventions assigned to this group

Tα1 group

Tα1 treatment for 3 months after surgery

Group Type EXPERIMENTAL

Thymosin Alpha1

Intervention Type DRUG

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

Interventions

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Thymosin Alpha1

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

Intervention Type DRUG

Other Intervention Names

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Tα1 Thymalfasin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yousheng Mao

OTHER

Sponsor Role lead

Responsible Party

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Yousheng Mao

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Yousheng Mao

Role: PRINCIPAL_INVESTIGATOR

National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital

Locations

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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

Site Status RECRUITING

Countries

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China

Central Contacts

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Yousheng Mao

Role: CONTACT

8610-67781331

Li Fu

Role: CONTACT

Facility Contacts

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Yousheng Mao

Role: primary

+86-010-67781331

Other Identifiers

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NCC4407

Identifier Type: OTHER

Identifier Source: secondary_id

NCC4407

Identifier Type: -

Identifier Source: org_study_id

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