Dynamic Observational Strategy for Stage IB-IIIA Non-Small Cell Lung Cancer Patients After Complete Resection Based on Longitudinal Undetectable Molecular Residual Disease: Prospective, Multicenter, Single-Arm Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 6
- 主要终点
- Two-years disease free survival rates for patients with longitudinal undetectable MRD
研究概览
简要总结
Molecular residual disease (MRD) has strong relationship with clinical outcome in multiple solid tumors. Here, the investigators try to verify the negative predictive value of undetectable MRD, which is considered as a superior prognostic factor for resected NSCLC patients, and not requiring excessive adjuvant therapy. Stage IB-IIIA resected NSCLC patients with landmark and longitudinal undetectable MRD are enrolled and under close surveillance in this study.
详细描述
Stage IB-IIIA resected NSCLC patients will undergo two-round MRD tests after operation, first in 3-7 days and second in 1 month after operation. Patients who confirm two-round landmark undetectable MRD will be enrolled to be under close MRD and imaging monitoring without any adjuvant therapy. Patients who are MRD positive during the two-round MRD screening period will receive treatment and follow-up in accordance with Clinical Practice Guidelines.
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
- •Stage IB-IIIA non-small cell cancer patients who after complete resection.
- •≥18 years.
- •Two-round MRD tests confirm landmark undetectable MRD.
- •Expected survival ≥12 weeks.
- •Expected survival ≥12 weeks.
- •ECOG PS 1-
- •Willing to accept MRD monitoring every 3 months for a total of 2 years after operation.
排除标准
- •Patients who had previously undergone radiotherapy or chemotherapy or any other anti-tumor therapy.
- •Patients with a history of other malignancies in the past 5 years.
- •Any unstable systemic disease (eg, active infection, high-risk hypertension, unstable angina, congestive heart failure, etc.).
研究组 & 干预措施
Undetectable MRD
Stage IB-IIIA NSCLC patients who after complete resection. And patients who maintain MRD negativity in two-round MRD landmark test (first in 3-7 days after surgery, second in 1 months ±7 days after surgery) will be enrolled. And patients will be under close dynamic monitoring at least two years.
干预措施: Molecular residual disease test (Diagnostic Test)
结局指标
主要结局
Two-years disease free survival rates for patients with longitudinal undetectable MRD
时间窗: 2 year
The 2-year DFS rate of patients who maintain 2-years undetectable MRD.
次要结局
- Two-years disease free survival rates for patients with 18-months longitudinal undetectable MRD(2 year)
- Two-years event-free survival rates for enrolled patients in two years(2 year)
- Two-years disease free survival rates for patients with six months longitudinal undetectable MRD(2 year)
- Two-years disease free survival rates for patients with 12-months longitudinal undetectable MRD(2 year)
- Two-years disease free survival rates for patients who tested positive for MRD and failed screening during the two-round MRD tests.(2 year)
研究者
Yi-Long Wu
Principal Investigator
Guangdong Association of Clinical Trials