Not yet recruiting NCT07391007
Integrated Clinical-molecular Risk Stratification to Early Recurrence in Colorectal Liver Metastases
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: gene sequencing, observational study.
- Who it may be relevant to
- Registry conditions: Colorectal Liver Metastases. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multidimensional Early-Recurrence Risk Stratification System and Personalized Treatment for Colorectal Cancer Liver Metastases: A Prospective Clinical Study
Overview
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?
Interventions
- Other gene sequencing
All patients will be performed gene sequencing in this study - Other observational study
Observational Study
Primary outcome measures
- Model Performance [Time frame: 2-years]
- 2-year recurrence free survival [Time frame: From enrollment to the end of recurrence at 2 years]
Secondary outcome measures (1)
- 3-years overall survival [Time frame: From enrollment to the end of death at 3 years]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Fudan University Shanghai Cancer Center — Shanghai
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. PMID 36347967
- 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 28233803
- 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 27125753
- 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 PMID 38631269
- 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 38806657
Identifiers
NCT: NCT07391007 · 2025-Exp196-KY