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

Starting soon

Conditions studied: Colorectal Liver Metastases

In brief

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?

Key facts

Study ID

NCT07391007

Run by

Fudan University

People needed

200

Starts

2026-01-31

Expected to finish

2028-04-30

Last updated by the study team

2026-02-05

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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