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NCT Number: NCT07391007

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

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?

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

gene sequencing

Other

All patients will be performed gene sequencing in this study

observational study

Other

Observational Study

Primary outcomes

  1. 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. 2-year recurrence free survival

    Time frame: From enrollment to the end of recurrence at 2 years

Secondary outcomes

  1. 3-years overall survival

    Time frame: From enrollment to the end of death at 3 years

Study contacts

Contact information is provided by the study sponsor or research team.

Yibin Wu, MD, PhD

CONTACT

[email protected]

8618121299890

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 5, 2026
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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