Prediction of Hepatocellular Carcinoma Recurrence After Curative Treatment by Longitudinal Monitoring Minimal Residual Disease Based on Circulating Tumor DNA
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 255
- 试验地点
- 7
- 主要终点
- 2-year recurrence-free survival rate
研究概览
简要总结
This study will conduct a prospective cohort study to verify the predictive value of ctDNA-MRD longitudinal monitoring model in predicting postoperative recurrence, verify whether ctDNA-MRD longitudinal monitoring model can indicate recurrence earlier than imaging examination, and explore the feasibility of guiding adjuvant therapy after curative treatment based on this model.
详细描述
The recurrence rate of hepatocellular carcinoma after curative treatment is high, and the minimal residual disease(MRD) in patients is the major cause of liver cancer recurrence, and the MRD is an important basis for the decision of adjuvant therapy after curative treatment. Previous studies have confirmed that circulating tumor DNA(ctDNA)-MRD monitoring model can accurately predict the recurrence of hepatocellular carcinoma patients. It was also found in retrospective analysis that tumor free survival was significantly prolonged after ctDNA-positive treatment for hepatocellular carcinoma after resection. This study will conduct a prospective cohort study to verify the predictive value of ctDNA-MRD longitudinal monitoring model in predicting postoperative recurrence, verify whether ctDNA-MRD longitudinal monitoring model can indicate recurrence earlier than imaging examination, and explore the feasibility of guiding adjuvant therapy after curative treatment based on this model.This study is to verify the predictive value of ctDNA-MRD longitudinal monitoring model in predicting postoperative recurrence.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients aged 18-75 years;
- •Preoperative imaging examination diagnosed hepatocellular carcinoma (BCLC) stage 0 / stage A/stage B, eligible for radical surgery;
- •ECOG physical status score is 0-1;
- •Child-Pugh score is 5-6 points (Level A);
- •Not received any anti-tumor therapy;
- •Laboratory tests were at normal levels within 7 days before enrollment.
排除标准
- •Patient can't provide blood samples for ctDNA testing;
- •Patient with two or more types of tumors at the same time;
- •Non-primary liver lesions;
- •Pregnant or lactating women;
- •Patient with a history of other malignant tumors within the past 5 years or at the same time, except cured skin basal cell carcinoma, cervical carcinoma in situ and thyroid papillary carcinoma;
- •Patient with serious heart disease;
- •Other conditions deemed unsuitable for inclusion by the researcher.
结局指标
主要结局
2-year recurrence-free survival rate
时间窗: 2 years
percentage of recurrence-free survival 2 years after surgery
次要结局
- Correlation between ctDNA-MRD status dynamic changes and relapse(2 years)