NCT06598839招募中不适用
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
Yousheng Mao1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年6月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of CTCs
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Tα1 group
Experimental
Tα1 treatment for 3 months after surgery
干预措施: Thymosin Alpha1 (Drug)
结局指标
主要结局
Number of CTCs
时间窗: 4 months after sugery
Number of peripheral blood circulating tumor cells after Tα1 treatment
次要结局
- Number of immune cells(4 months after sugery)
- Peripheral blood immune cells profile(4 months after sugery)
- AE(within 4 months after sugery)
研究者
Yousheng Mao
Professor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
研究点 (1)
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