Colorectal Liver MetastasesNCT07391007
Integrated Clinical-molecular Risk Stratification to Early Recurrence in Colorectal Liver Metastases
An observational study of Colorectal Liver Metastases, run by Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Liver Metastases
- What is being tested?
- gene sequencing and observational study
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 31 Jan 2026to 30 Apr 2028
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients were diagnosed with resectable colorectal liver metastases
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
About this study
Official title: A Multidimensional Early-Recurrence Risk Stratification System and Personalized Treatment for Colorectal Cancer Liver Metastases: A Prospective Clinical Study
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?
- Conditions
- Colorectal Liver Metastases
- Being tested
- gene sequencing, observational study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gene sequencingOther
All patients will be performed gene sequencing in this study
observational studyOther
Observational Study
| Study group | Role | What they receive |
|---|---|---|
| FUSCC Prospective Cohort | FUSCC Prospective Cohort Receives: Other: gene sequencing; Other: observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Model Performance
We used the area under the ROC curve (AUC) and calibration curves to evaluate the predictive performance of the model.
Measured: 2-years
2-year recurrence free survival
Measured: From enrollment to the end of recurrence at 2 years
Secondary outcomes (1)
3-years overall survival
Measured: From enrollment to the end of death at 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start31 Jan 2026 (estimated)
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Colorectal Liver MetastasesStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yibin Wu, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07391007
- Sponsor's protocol ID
- 2025-Exp196-KY
- Status last verified
- Jan 2026
- First submitted
- 29 Jan 2026
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 36347967Wan 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.
PubMed 28233803Imai 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.
PubMed 27125753Moretto 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.
PubMed 38631269Canellas-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.
PubMed 38806657
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multidimensional Early-Recurrence Risk Stratification System and Personalized Treatment for Colorectal Cancer Liver Metastases: A Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT07391007
- Acronym / sponsor ID
- 2025-Exp196-KY
- Conditions
- Colorectal Liver Metastases
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 31 Jan 2026 (estimated)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 5 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FUSCC Prospective Cohort | – | Other: gene sequencing, Other: observational studyFUSCC Prospective Cohort |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients were diagnosed with resectable colorectal liver metastases
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gene sequencingAll patients will be performed gene sequencing in this study | Other | FUSCC Prospective Cohort |
| observational studyObservational Study | Other | FUSCC Prospective Cohort |
Primary outcome
Model Performance
Time frame: 2-years
We used the area under the ROC curve (AUC) and calibration curves to evaluate the predictive performance of the model.
2-year recurrence free survival
Time frame: From enrollment to the end of recurrence at 2 years
1 secondary outcome
3-years overall survival
Time frame: From enrollment to the end of death at 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Results publication: PubMed 36347967Faulkner 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.
- Results publication: PubMed 28233803Wan 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.
- Results publication: PubMed 27125753Imai 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.
- Results publication: PubMed 38631269Moretto 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.
- Results publication: PubMed 38806657Canellas-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.
- Individual participant dataSharing planned: No. 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.
Related trials for Colorectal Liver Metastases
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
Not yet recruiting
RAPID for Unresectable Colorectal Liver Metastases
Colorectal Liver Metastases (CRCLM), Colorectal Neoplasms
RecruitingPhase 2
Circulating Tumor DNA Methylation-Guided Adjuvant Therapy Decision-Making in Patients With Resectable Colorectal Cancer Liver Metastases After Resection
Colorectal Cancer Liver Metastases (CRLM), ctDNA
RecruitingObservational study
Cancer Experience Registry (CER) for Cancer Patients and Caregivers
Neoplasms, Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Liver Metastases, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yibin Wu, MD, PhD (8618121299890, yibinwu@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Model Performance (time frame: 2-years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07391007, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.