Integrated Clinical-molecular Risk Stratification to Early Recurrence in Colorectal Liver Metastases
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: gene sequencing, observational study.
- Кому может быть актуально
- Состояния в реестре: Colorectal Liver Metastases. Базовые параметры: 18 лет — 75 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Китай
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
A Multidimensional Early-Recurrence Risk Stratification System and Personalized Treatment for Colorectal Cancer Liver Metastases: A Prospective Clinical Study
Обзор
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?
Вмешательства
- Другое gene sequencing
All patients will be performed gene sequencing in this study - Другое observational study
Observational Study
Первичные конечные точки
- Model Performance [Срок оценки: 2-years]
- 2-year recurrence free survival [Срок оценки: From enrollment to the end of recurrence at 2 years]
Вторичные конечные точки (1)
- 3-years overall survival [Срок оценки: From enrollment to the end of death at 3 years]
Критерии участия
Критерии включения
- 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.
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Китай · 1 центр
- Fudan University Shanghai Cancer Center — Шанхай
Публикации
- 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
Идентификаторы
NCT: NCT07391007 · 2025-Exp196-KY