Integrated Clinical-molecular Risk Stratification to Early Recurrence in Colorectal Liver Metastases

A Multidimensional Early-Recurrence Risk Stratification System and Personalized Treatment for Colorectal Cancer Liver Metastases: A Prospective Clinical Study

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07391007

Enrollment

200

Registered

2026-02-05

Start date

2026-01-31

Completion date

2028-04-30

Last updated

2026-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Liver Metastases

Brief 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?

Interventions

OTHERgene sequencing

All patients will be performed gene sequencing in this study

OTHERobservational study

Observational Study

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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	—

Secondary

Measure	Time frame
3-years overall survival	From enrollment to the end of death at 3 years

Countries

China

Contacts

CONTACTYibin Wu, MD, PhD

yibinwu@fudan.edu.cn8618121299890

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026