Minimal Residual Disease (MRD) Guided Prognosis Prediction and Adjuvant Treatment Based on Expression and Mutational Signatures of Circulating Tumor Cell (CTC) and Circulating Tumor DNA (ctDNA) in Non-small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To evaluate the Progression-free Survival (PFS)
研究概览
简要总结
This is a prospective cohort study, which aims to evaluate the effectiveness and superiority of a novel minimal residual disease-guided prognosis monitoring and adjuvant treatment in stage IIA-IIIC non-small cell lung cancer.
详细描述
This observational study is a single-center, prospective cohort study, which aims to detect minimal residual disease (MRD) using circulating tumor cells (CTC) and circulating tumor DNA (ctDNA). To evaluate the effectiveness and superiority of MRD detection, we enroll operable or inoperable IIA-IIIC stage NSCLC patients, and single-cell RNA sequencing and genomic sequencing would be performed for CTC and ctDNA, respectively.
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 signed before implementing any enrollment-related procedures;
- •Age ≥18 years old;
- •Patients with histologically or cytologically confirmed stage IIA-IIIC NSCLC (International Association for the Study of Lung Cancer and American Joint Committee on Classification of Cancer, 8th Edition TNM staging)；
- •There is no special restriction on the source of genetic test report.
- •According to the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1), there is at least one radiographically measurable lesion.
- •Have not received any previous systemic antitumor therapy for advanced diseases.
- •No serious abnormalities of hematopoietic function, heart, lung, liver, kidney function and immune system.
- •ECOG score: 0-1;
- •Expected survival time > 3 months.
排除标准
- •Received surgical treatment for lung tumors.
- •Received neoadjuvant chemotherapy or radiotherapy.
- •Received cellular therapy within the last 1 year.
- •Treated but uncontrolled diabetes, mellitus, asthma, autoimmune diseases and other chronic diseases.
- •Participated in other clinical trials (including research vaccines, drugs, medical devices, etc.) within one month.
结局指标
主要结局
To evaluate the Progression-free Survival (PFS)
时间窗: From the first study dose date to the date of first documentation of disease progression or death (whichever occurred first), up to approximately 3 years
Progression-free survival (PFS) is defined as the time from the start of treatment to the occurrence of tumor progression or death due to any cause based on RECIST 1.1 assessed by investigator review.
次要结局
- To evaluate the Overall Survival (OS)(From the date of first dose of study drug until date of death from any cause (up to approximately 5 years ))
研究者
Rong Yin, MD PhD
Professor
Jiangsu Cancer Institute & Hospital