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

January 29, 2026 updated by: Yibin Wu, Fudan University

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

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?

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Fudan University Shanghai Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients were diagnosed with resectable colorectal liver metastases

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
FUSCC Prospective Cohort
Other: observational study
Observational Study
Other: gene sequencing
All patients will be performed gene sequencing in this study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Model Performance
Time Frame: 2-years
We used the area under the ROC curve (AUC) and calibration curves to evaluate the predictive performance of the model.
2-years
2-year recurrence free survival
Time Frame: From enrollment to the end of recurrence at 2 years
From enrollment to the end of recurrence at 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
3-years overall survival
Time Frame: From enrollment to the end of death at 3 years
From enrollment to the end of death at 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 31, 2026

Primary Completion (Estimated)

April 30, 2028

Study Completion (Estimated)

April 30, 2028

Study Registration Dates

First Submitted

January 29, 2026

First Submitted That Met QC Criteria

January 29, 2026

First Posted (Actual)

February 5, 2026

Study Record Updates

Last Update Posted (Actual)

February 5, 2026

Last Update Submitted That Met QC Criteria

January 29, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-Exp196-KY

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The ownership and usage rights of the data from this study are subject to agreements with the participating institutions, funding organizations, and sample providers. These agreements stipulate that the data may only be used for the specific purposes of this project and, therefore, cannot be publicly shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Colorectal Liver Metastases

Clinical Trials on observational study

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Nigeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe