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

Fudan University

Status: Not yet enrolling

Conditions: Colorectal Liver Metastases

Treatments: Other: gene sequencing; Other: observational study

Study type: Observational

Funder types: Other

Identifiers

NCT07391007

2025-Exp196-KY

Details and patient eligibility

About

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?

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

200 participants in 1 patient group

FUSCC Prospective Cohort

Description:

FUSCC Prospective Cohort

Treatment:

Other: gene sequencing

Other: observational study