NCT05648370招募中不适用
Liquid Biopsy in Advanced Oligometastatic NSCLC Receiving Surgery
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Association between perioperative ctDNA-MRD characteristics and rogression-free survival
研究概览
简要总结
A prospective, observational study that assesses the clinical feasibility of ctDNA-based liquid biopsy in patients with oligometastatic NSCLC receiving surgery.
详细描述
60 eligible patients will be enrolled. Dynamic blood samples before and after surgery and tissue samples will be obtained for exploratory analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Written informed consent must be obtained from patients and ability for patients to comply with the requirements of the study；
- •Patients must be a man or woman of more than 18 years;
- •ECOG PS ≦1；
- •The function of the organs was evaluated by the surgeon to tolerate local surgical treatment；
- •The classification was evaluated as simultaneous oligometastases at initial treatment or oligoresidual/oligoprogression/oligorecurrence after induction therapy; [Define: Initial treatment of simultaneous oligometastases: without systemic treatment, at the time of diagnosis, up to 5 metastases and up to 3 organs were involved, excluding pleural metastases or myeloid metastases.
- •Oligoresidual after induction therapy: after systemic therapy, distant metastases were stable or reduced, primary lesions were stable or reduced, PET/CT metabolism was reduced, and no more than 5 residual lesions and no more than 3 organs were involved.
- •Oligoprogression after induction therapy: After systemic therapy, some lesions were stable or reduced, while some original lesions were larger than before.
- •Oligorelapses after induction therapy: after systemic therapy, systemic lesions were stable or reduced, and new local lesions appeared.]
- •Lesion evaluation can be surgically removed. [Definition of operable resection: the lesion is limited and can be completely removed through surgery as assessed by the surgeon, with no significant impact on postoperative quality of life. Pulmonary surgical procedures include lobectomy, segmental resection and wedge resection. Pneumonectomy is not included.]
排除标准
- •Patients with a confirmed or suspected autoimmune disease;
- •Patients with a history of human immunodeficiency virus (HIV) positive or acquired immunodeficiency syndrome (AIDS);
- •Patients with a history of any arterial thrombosis within 6 months and history of deep vein thrombosis, pulmonary embolism, or any other severe thromboembolism within 3 months;
- •Patients with any unstable systemic disease (eg, active infection, high-risk hypertension, unstable angina, congestive heart failure, etc.);
- •Patients with a history of other malignancies in the past 5 years;
- •Patients identified by the investigators patients with contraindications to local treatment;
- •Patients with serious mental illness;
- •Patients who cannot sign informed consent;
- •Patients who cannot be followed up as scheduled;
结局指标
主要结局
Association between perioperative ctDNA-MRD characteristics and rogression-free survival
时间窗: 2-year PFS
To explore the potential association among perioperative ctDNA-MRD characteristics and rogression-free survival within 2 years.
Construction of a survival-prediction model
时间窗: Through study completion, up to 5 years
The survival-prediction model based on clinicopathological and genomic characteristics.
次要结局
- Association among ctDNA status before surgery, systemic treatment times, and survival(Through study completion, up to 5 years)
- Heterogeneity in Genomic and transcriptome between primary and metastatic tumors(60 patients underwent surgery)
- Assess whether ctDNA-MRD is associated with radiological and pathological response after systematic therapy before surgery(60 patients underwent surgery)
- Potential drug-resistance mechanism identified by plasma ctDNA(Through study completion, up to 5 years)
- Genomic characteristics and clonal evolution after systemic treatment(Through study completion, up to 5 years)
研究者
研究点 (1)
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