Clinical trial · Observational
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
NCT07391007CI-TRIAL-00102525not yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Liver Metastases | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gene sequencing | Other | — | UNRESOLVED |
| observational study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- FUSCC Prospective Cohort
- description
- FUSCC Prospective Cohort
- interventionNames
- Other: gene sequencing
- Other: observational study
Primary outcomes (2)
- measure
- Model Performance
- timeFrame
- 2-years
- description
- We used the area under the ROC curve (AUC) and calibration curves to evaluate the predictive performance of the model.
- measure
- 2-year recurrence free survival
- timeFrame
- From enrollment to the end of recurrence at 2 years
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (5)
- RESULTFaulkner 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 36347967
- RESULTWan 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 28233803
- RESULTImai 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 27125753
- RESULTMoretto 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 38631269
- RESULTCanellas-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 38806657