NCT07391007Not yet recruiting
Integrated Clinical-molecular Risk Stratification to Early Recurrence in Colorectal Liver Metastases
A Multidimensional Early-Recurrence Risk Stratification System and Personalized Treatment for Colorectal Cancer Liver Metastases: A Prospective Clinical Study
Source: ClinicalTrials.gov · Last updated 5 Feb 2026
Brief summary (registry, in English)
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?
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 29 Jan 2026
- Start date
- 31 Jan 2026
- Primary completion date
- 30 Apr 2028
- Lead sponsor
- Fudan University
- Diseases
- Colorectal cancer
- NCT number
- NCT07391007
What you commit to
- Study type: Observational
- Planned participants: 200
- From 31 Jan 2026 to the primary completion date, 30 Apr 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
- Allergic to any component of the therapy
- Severe uncontrolled recurrent infections
Lab values
- 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
Other
- Pregnancy or breast-feeding women
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.