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OpenTrials
Completed

NCT Number: NCT06023173

Deep Radiomics-based Fusion Model Predicting Bevacizumab Treatment Response and Outcome in Patients With Colorectal Liver Metastases

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of General Surgery, Zhongshan Hospital, Fudan University

Shanghai, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Deep radiomics-based fusion model

Diagnostic Test

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

Other names: deep learning model

Primary outcomes

  1. ORR

    Time frame: 2013.10.1-2023.1.1

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

  2. PFS

    Time frame: 2013.10.1-2023.1.1

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

Secondary outcomes

  1. OS

    Time frame: 2013.10.1-2023.1.1

    Overall survival of patients with colorectal cancer liver metastases who treated with FOLFOX+bevacizumab/FOLFOX

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2023
Study completion
2023
First posted
Sep 5, 2023
Registry last updated
Sep 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.