Individualized Tumor-Informed Circulating Tumor DNA (ctDNA) Analysis for Monitoring Postoperative Recurrence Following Neoadjuvant Therapy in Esophageal Squamous Cell Carcinoma (NEOCRTEC2401)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 主要终点
- Correlation between the recurrence of patients and the quantitative measurement of circulating tumor DNA (ctDNA) concentration.
研究概览
简要总结
The goal of this observational study or is to explore the correlation between dynamic changes in postoperative circulating tumor DNA (ctDNA) and recurrence risk using a novel, tumor-informed ctDNA detection technique, thus laying the foundation for further promoting ctDNA detection to guide postoperative adjuvant therapy decisions. This study focuses on patients with esophageal squamous cell carcinoma who did not achieve pCR following neoadjuvant therapy combined with surgical resection. The main question it aims to answer is:
Is there a correlation between postoperative ctDNA changes and tumor recurrence?
Participants will be asked to undergo postoperative ctDNA detection.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Operable locally advanced esophageal squamous cell carcinoma;
- •Have received neoadjuvant chemoradiotherapy ± immunotherapy and have not achieved pCR after R0 resection;
- •Can tolerate postoperative adjuvant immunotherapy;
- •Sufficient baseline tumor tissue and blood samples available for NGS testing;
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
- •Consents to and is capable of complying with the scheduled study visits, treatment plans, laboratory tests, and other study procedures
- •Expected postoperative survival time of ≥ 6 months.
排除标准
- •Concurrent other malignant tumors;
- •Lack of a detailed histopathological diagnostic report for determining the nature of the lesion;
- •Severe and/or poorly controlled medical conditions that, in the investigator's judgment, could affect participation or interfere with study results;
- •Any social/psychological issues that, in the investigator's judgment, make the patient unsuitable for participation;
- •Unable to undergo long-term, regular postoperative follow-up at the current medical institution;
- •Unwilling or unable to comply with the study protocol.
结局指标
主要结局
Correlation between the recurrence of patients and the quantitative measurement of circulating tumor DNA (ctDNA) concentration.
时间窗: 3 years
Correlation were evaluated based on the sensitivity and specificity of ctDNA in predicting recurrence.The sensitivity and specificity were determined by evaluating the association between positive ctDNA and tumor recurrence.
次要结局
- 5-year disease-free survival(5 years)
- 2-year overall survival(2 years)
- Correlation between ctDNA detection and postoperative adjuvant therapy.(3 years)
- correlation between patients' prognosis and landmark MRD status(3 years)
- 5-year overall survival(5 years)
- Postoperative molecular residual disease (MRD) positive rate(3 years)
- 2-year disease-free survival(2 years)
- 3-year disease-free survival(3 years)
- 3-year overall survival(3 years)
研究者
Yang Hong
Prof.
Sun Yat-sen University