Efficacy Evaluation and Recurrence Monitoring of Neoadjuvant Therapy and Adjuvant Therapy for Esophageal Squamous Cell Carcinoma Based on ctDNA-MRD.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- pathological complete response (pCR)
研究概览
简要总结
This project is focusing on who have locally advanced esophageal squamous cell carcinoma and have undergone neoadjuvant and adjuvant therapy, followed by surgical resection. The exclusive MRD (Minimal residual disease) probe consists of an exclusive "molecular label" formulated according to the individual genome mutation profile and 21 critical tumor driver genes. By continuously monitoring each patient's ctDNA dynamics, changes in ctDNA concentration or ctDNA-MRD negative/positive results will serve as the primary indicators to assess the efficacy and prognosis of patients with esophageal squamous cell carcinoma.
详细描述
The goal of this project is to recruit 50 patients who have locally advanced esophageal squamous cell carcinoma and have undergone neoadjuvant and adjuvant therapy, followed by surgical resection. Initially, tumor tissues from all patients will undergo a more comprehensive NGS sequencing process (WESPlus) than whole-exome sequencing. This will provide a complete genomic mutation profile for each patient. Subsequently, a specific algorithm will be used to accurately select 20 mutation sites as the patient's unique "molecular label." Additionally, 21 critical driver genes related to tumors will be combined, leading to the creation of an exclusive MRD probe. This will enable ultra-high-depth capture sequencing of ctDNA samples from patients at 100,000x. By continuously monitoring each patient's ctDNA dynamics, changes in ctDNA concentration or ctDNA-MRD negative/positive results will serve as the primary indicators to assess the efficacy and prognosis of patients with esophageal squamous cell carcinoma.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range from 18 to 80 years old;
- •Patients diagnosed with locally advanced esophageal squamous cell carcinoma by imaging or pathological examination: cT2-4N1-3M0, cT3-4N0M0 II-IVA (including IVB stage with supraclavicular and abdominal lymph node metastasis);
- •Receive neoadjuvant therapy;
- •Must be able to obtain the patient's clinical information and clear pathological diagnosis results;
- •Able to cooperate with long-term follow-up, regular review, and blood sample collection;
- •Patients agree to participate in the tracking and follow-up of the group and provide follow-up information;
- •Must obtain the informed consent of the patient or their legal representative, and the patient has the ability to cooperate to complete the requirements of the study.
排除标准
- •Patients with other cancers or severe illnesses that result in shorter survival than the trial follow-up period;
- •Received other treatments (such as radiotherapy, etc.) before receiving neoadjuvant therapy;
- •Have contraindications to chemotherapy;
- •Patients who received blood transfusions within three months prior to enrollment;
- •HIV-positive patients or those with other immune system deficiency diseases;
- •Pregnant patients;
- •Alcohol or drug abusers;
- •Other situations that the researchers believe may affect the experimental results or are unethical.
结局指标
主要结局
pathological complete response (pCR)
时间窗: immediately after surgery
No residual tumor is the esophagus or dissected lymph nodes.
次要结局
- Overall survival (OS)(2 years)
- Recurrence-free survival (RFS)(2 years)