NCT07391007

Brief 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?

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
24mo left

Started Jan 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress12%
Jan 2026Apr 2028

First Submitted

Initial submission to the registry

January 29, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

January 31, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 5, 2026

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2028

Last Updated

February 5, 2026

Status Verified

January 1, 2026

Enrollment Period

2.2 years

First QC Date

January 29, 2026

Last Update Submit

January 29, 2026

Conditions

Colorectal Liver Metastases

Outcome Measures

Primary Outcomes (2)

  • Model Performance

    We used the area under the ROC curve (AUC) and calibration curves to evaluate the predictive performance of the model.

    2-years

  • 2-year recurrence free survival

    From enrollment to the end of recurrence at 2 years

Secondary Outcomes (1)

  • 3-years overall survival

    From enrollment to the end of death at 3 years

Study Arms (1)

FUSCC Prospective Cohort

FUSCC Prospective Cohort

Other: gene sequencingOther: observational study

Interventions

gene sequencingOTHER

All patients will be performed gene sequencing in this study

FUSCC Prospective Cohort
observational studyOTHER

Observational Study

FUSCC Prospective Cohort

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients were diagnosed with resectable colorectal liver metastases

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (5)

  • Faulkner LG, Howells LM, Pepper C, Shaw JA, Thomas AL. The utility of ctDNA in detecting minimal residual disease following curative surgery in colorectal cancer: a systematic review and meta-analysis. Br J Cancer. 2023 Jan;128(2):297-309. doi: 10.1038/s41416-022-02017-9. Epub 2022 Nov 8.

    PMID: 36347967RESULT

  • Wan JCM, Massie C, Garcia-Corbacho J, Mouliere F, Brenton JD, Caldas C, Pacey S, Baird R, Rosenfeld N. Liquid biopsies come of age: towards implementation of circulating tumour DNA. Nat Rev Cancer. 2017 Apr;17(4):223-238. doi: 10.1038/nrc.2017.7. Epub 2017 Feb 24.

    PMID: 28233803RESULT

  • Imai K, Allard MA, Benitez CC, Vibert E, Sa Cunha A, Cherqui D, Castaing D, Bismuth H, Baba H, Adam R. Early Recurrence After Hepatectomy for Colorectal Liver Metastases: What Optimal Definition and What Predictive Factors? Oncologist. 2016 Jul;21(7):887-94. doi: 10.1634/theoncologist.2015-0468. Epub 2016 Apr 28.

    PMID: 27125753RESULT

  • Moretto R, Germani MM, Borelli B, Conca V, Rossini D, Boraschi P, Donati F, Urbani L, Lonardi S, Bergamo F, Cerma K, Ramondo G, D'Amico FE, Salvatore L, Valente G, Barbaro B, Giuliante F, Di Maio M, Masi G, Cremolini C. Predicting early recurrence after resection of initially unresectable colorectal liver metastases: the role of baseline and pre-surgery clinical, radiological and molecular factors in a real-life multicentre experience. ESMO Open. 2024 Apr;9(4):102991. doi: 10.1016/j.esmoop.2024.102991. Epub 2024 Apr 16.

    PMID: 38631269RESULT

  • Canellas-Socias A, Sancho E, Batlle E. Mechanisms of metastatic colorectal cancer. Nat Rev Gastroenterol Hepatol. 2024 Sep;21(9):609-625. doi: 10.1038/s41575-024-00934-z. Epub 2024 May 28.

    PMID: 38806657RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Tumor sample tissues from liver metastatic lesions and poseoperative blood samples at month 1 (before adjuvant chemotherapy)

MeSH Terms

Interventions

Base SequenceObservation

Intervention Hierarchy (Ancestors)

Molecular StructureBiochemical PhenomenaChemical PhenomenaGenetic StructuresGenetic PhenomenaMethodsInvestigative Techniques

Central Study Contacts

Yibin Wu, MD, PhD

CONTACT

8618121299890yibinwu@fudan.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Fudan University Shanghai Cancer Center

Study Record Dates

First Submitted

January 29, 2026

First Posted

February 5, 2026

Study Start

January 31, 2026

Primary Completion (Estimated)

April 30, 2028

Study Completion (Estimated)

April 30, 2028

Last Updated

February 5, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

The ownership and usage rights of the data from this study are subject to agreements with the participating institutions, funding organizations, and sample providers. These agreements stipulate that the data may only be used for the specific purposes of this project and, therefore, cannot be publicly shared.

Locations

CN(1)