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Clinical Trials in China / NCT07391007
Starting soon Observational

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

NCT07391007 · tracked via the Priya Life Science China tracker
Sponsor
Fudan University
Phase
Observational
Started
2026-01-31
Last updated
2026-02-05

Condition(s) studied

Colorectal Liver Metastases

Investigational drug(s) / intervention(s)

gene sequencingobservational study

gene sequencing: All patients will be performed gene sequencing in this study

observational study: Observational Study

Study 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?

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Fudan University Shanghai Cancer Center Shanghai Shanghai Municipality

More Fudan University trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07391007 on ClinicalTrials.gov ↗ ← All trials in China