Study Results
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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RECRUITING
NA
40 participants
INTERVENTIONAL
2024-06-30
2025-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control group
only observation after surgery
No interventions assigned to this group
Tα1 group
Tα1 treatment for 3 months after surgery
Thymosin Alpha1
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Yousheng Mao
OTHER
Responsible Party
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Yousheng Mao
Professor
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
Countries
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Central Contacts
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Facility Contacts
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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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