A Multidimensional Early-Recurrence Risk Stratification System and Personalized Treatment for Colorectal Cancer Liver Metastases: A Prospective Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Model Performance
研究概览
简要总结
The goal of this observational study is to develop an integrated clinical-molecular risk stratification to identifypatients who are at high risk of recurrence and who would benefit from adjuvant chemotherapy in patients with recectable colorectal liver metastases. The main question it aims to answer is: can the integration of multi-dimensional data-including ctDNA, driver gene profiles, and clinical factors-accurately identify postoperative patients at high risk of recurrence and guide personalized adjuvant therapy strategies?
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
- •Aged 18 to 75 years, inclusive (male or female).
- •Pathologically and radiologically confirmed colorectal cancer with liver metastases.
- •Must have undergone complete (R0) surgical resection of both the primary colorectal tumor and all liver metastases.
- •Have adequate organ function and no contraindications to potential adjuvant therapies (surgery, chemotherapy, radiotherapy, immunotherapy).
- •Willing and able to comply with the study protocol and follow-up visits.
- •Availability of sufficient liver metastasis tumor tissue for gene sequencing.
- •Provision of a blood sample for circulating tumor DNA (ctDNA) detection within one month after surgery but before starting any adjuvant therapy.
排除标准
- •Pregnancy or breast-feeding women
- •History of other malignancies within 5 years (except cured skin cancer and cervicalcancer in situ)
- •History of uncontrolled epilepsy, central nervous system disease, or psychiatricdisorders
- •Clinically serious heart disease, such as symptomatic coronary artery disease, NewYork Heart Association (NYHA) class II or worse congestive heart failure or severearrhythmia requiring pharmacologic intervention, or history of myocardial infarctionwithin the last 12 months
- •Baseline blood and biochemical indicator do not meet the following criteria:neutrophils >=1.5×10^9/L, Hb >=90g/L, PLT >=100×10^9/L, ALT/AST<=2.5 ULN, Cr <= 1ULN
- •Allergic to any component of the therapy
- •Severe uncontrolled recurrent infections
研究组 & 干预措施
FUSCC Prospective Cohort
FUSCC Prospective Cohort
干预措施: gene sequencing (Other)
FUSCC Prospective Cohort
FUSCC Prospective Cohort
干预措施: observational study (Other)
结局指标
主要结局
Model Performance
时间窗: 2-years
We used the area under the ROC curve (AUC) and calibration curves to evaluate the predictive performance of the model.
2-year recurrence free survival
时间窗: From enrollment to the end of recurrence at 2 years
次要结局
- 3-years overall survival(From enrollment to the end of death at 3 years)
研究者
Yibin Wu
Fudan University Shanghai Cancer Center
Fudan University