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

Completed

• Conditions: The Patients With CRLM Who Benefit More From Bevacizumab
• Interventions: Diagnostic Test: Deep radiomics-based fusion model

• Registration Number: NCT06023173
• Lead Sponsor: Fudan University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2013-10-01
• Primary Completion: 2023-01-01
• Study Completion: 2023-01-01
• Status Verified: 2023-08
• Study First Submitted: 2023-08-29
• Study First Submitted QC: 2023-08-29
• Study First Posted: 2023-09-05
• Last Update Submitted: 2023-09-13
• Last Update Posted: 2023-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 307

Inclusion Criteria

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

Exclusion Criteria

1. Resectable liver metastases;
2. Wide-type KRAS/NRAS;
3. No measurable liver metastasis;
4. No efficacy assessment;
5. No follow-up information.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Training Cohort	Deep radiomics-based fusion model	This cohort was derived from Arm A (treated with FOLFOX + bevacizumab) of the BECOME studyand was used for model construction.
External Validation Cohort	Deep radiomics-based fusion model	The cohort was obtained from the Zhongshan Hospital - Xiamenand the First Affiliated Hospital of Wenzhou Medical University for external validation of the model.
Negative Validation Cohort	Deep radiomics-based fusion model	The cohort was derived from Arm B (treated with FOLFOX) of the BECOME study , which demonstrated that the model specifically predicted the efficacy of bevacizumab.
Internal Validation Cohort	Deep radiomics-based fusion model	The cohort was derived from an independent Zhongshan Hospital cohort with the same treatment team and imaging instrumentation as the BECOME study, differing only in patient period, and was used for internal validation of the model.

Primary Outcome Measures

Name	Time	Method
PFS	2013.10.1-2023.1.1	Progression-free survival of patients with colorectal cancer liver metastases who treated with FOLFOX+bevacizumab/FOLFOX
ORR	2013.10.1-2023.1.1	Objective response rate of patients with colorectal cancer liver metastases who treated with FOLFOX+bevacizumab/FOLFOX

Secondary Outcome Measures

Name	Time	Method
OS	2013.10.1-2023.1.1	Overall survival of patients with colorectal cancer liver metastases who treated with FOLFOX+bevacizumab/FOLFOX

Trial Locations

Locations (1)

Department of General Surgery, Zhongshan Hospital, Fudan University; 🇨🇳 Shanghai, China