gene sequencing: All patients will be performed gene sequencing in this study
observational study: Observational Study
Study summary
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?
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. Aged 18 to 75 years, inclusive (male or female).
2. Pathologically and radiologically confirmed colorectal cancer with liver metastases.
3. Must have undergone complete (R0) surgical resection of both the primary colorectal tumor and all liver metastases.
4. Have adequate organ function and no contraindications to potential adjuvant therapies (surgery, chemotherapy, radiotherapy, immunotherapy).
5. Willing and able to comply with the study protocol and follow-up visits.
6. Availability of sufficient liver metastasis tumor tissue for gene sequencing.
7. Provision of a blood sample for circulating tumor DNA (ctDNA) detection within one month after surgery but before starting any adjuvant therapy.
Exclusion Criteria:
1. Pregnancy or breast-feeding women
2. History of other malignancies within 5 years (except cured skin cancer and cervicalcancer in situ)
3. History of uncontrolled epilepsy, central nervous system disease, or psychiatricdisorders
4. 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
5. 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
6. Allergic to any component of the therapy
7. Severe uncontrolled recurrent infections
Primary outcome measure(s)
Model Performance — 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 — From enrollment to the end of recurrence at 2 years
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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