Neoadjuvant Anti-PD-1 Therapy in Early Stage Non-small-cell Lung Cancer Presenting as Synchronous Ground-glass Nodules: a Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- XiangNing Fu
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Objective Response Rate
研究概览
简要总结
Neoadjuvant Immunotherapy in Early Stage Non-small-cell Lung Cancer Presenting as Synchronous Ground-glass Nodules: a pilot study
详细描述
In many cases, non-small-cell lung cancer(NSCLC) manifested as synchronous ground-glass nodules(GGNs) and makes complete surgical resection impossible. At the same time, there is no good solution for the remaining GGNs after resection of the main lesion. Theoretically, pre-operative anti-PD-1 therapy is optimal for promoting anti-tumor immune response on the basis of maximum tumor mutational burden (TMB). In addition, neoadjuvant immunotherapy should have long-term anti-tumor effect even after surgery, because tumor recurrence may cause memory cells activation and differentiation. This is a pilot study to analysis the pathological remission rate of neoadjuvant immunotherapy and adverse events related to the treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •not less than two GGNs on chest CT
- •at least one lesion is diagnosed as NSCLC from biopsy pathology
- •no contraindication for surgery
- •ECOG score of 0 or 1
- •no detectable evidence of distant metastasis
排除标准
- •medical history of malignancy
- •pregnant or breeding period
- •severe organ failure (heart, liver, kidney, and lung)
- •high risk of cerebral-cardiovascular evens
- •infection out of control
- •received or receiving chemo- and radiotherapy
- •history of severe reaction due to allergy or hypersensitivity
- •severe mental disorder
- •currently been enrolled in other trials
- •autoimmune or chronic inflammatory disease
研究组 & 干预措施
neoadjuvant PD-1 group
receiving neoadjuvant therapy of programmed death-1 (pd-1) immune checkpoint inhibitor
干预措施: Tislelizumab Injection (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: twelve weeks
次要结局
- treatment-related adverse events(three months)