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临床试验/NCT06023173
NCT06023173已完成不适用

Deep Radiomics-based Fusion Model Predicting Bevacizumab Treatment Response and Outcome in Patients With Colorectal Liver Metastases: a Multicenter Cohort Study

Fudan University1 个研究点 分布在 1 个国家目标入组 307 人开始时间: 2013年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
307
试验地点
1
主要终点
PFS

研究概览

简要总结

This multi-modal deep radiomics model, using PET/CT, clinical and histopathological data, was able to identify patients with bevacizumab-sensitive unresectable colorectal cancer liver metastases, providing a favorable approach for precise patient treatment.

详细描述

Accurately predicting tumor response to targeted therapies is essential for guiding personalized conversion therapy in patients with unresectable colorectal cancer liver metastases (CRLM). Currently, tumor response evaluation criteria are based on assessments made after at least 2-months treatment. Consequently, there is a compelling need to develop baseline tools that can be used to guide therapy selection. Herein, the investigators proposed a deep radiomics-based fusion model which demonstrates high accuracy in predicting the efficacy of bevacizumab in CRLM patients. Further, the investigators observed a significant and positive association between the predicted-responders and longer progression-free survival as well as longer overall survival in CRLM patients treated with bevacizumab. Moreover, the model exhibits high negative prediction value, indicating its potential to accurately identify individuals who are unresponsive to bevacizumab. Thus, our model provides a valuable baseline method for specifically identifying bevacizumab-sensitive CRLM patients, which is offering a clinically convenient approach to guide precise patient treatment.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years and ≤75 years;
  • Patients were histologically confirmed for colorectal adenocarcinoma with unresectable liver-limited or liver-dominant metastases
  • PET/CT at baseline were available
  • First line treated with FOLFOX+ bevacizumab.

排除标准

  • Resectable liver metastases;
  • Wide-type KRAS/NRAS;
  • No measurable liver metastasis;
  • No efficacy assessment;
  • No follow-up information.

结局指标

主要结局

PFS

时间窗: 2013.10.1-2023.1.1

Progression-free survival of patients with colorectal cancer liver metastases who treated with FOLFOX+bevacizumab/FOLFOX

ORR

时间窗: 2013.10.1-2023.1.1

Objective response rate of patients with colorectal cancer liver metastases who treated with FOLFOX+bevacizumab/FOLFOX

次要结局

  • OS(2013.10.1-2023.1.1)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Xu jianmin

Head of Colorectal Surgery

Fudan University

研究点 (1)

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