Multimodal Deep Learning Signature for Evaluation of Response to Bevacizumab in Patient With Colorectal Cancer Liver Metastasis

Not yet recruiting

• Conditions: Liver Metastases; Colorectal Cancer
• Interventions: Drug: Bevacizumab

• Registration Number: NCT05354674
• Lead Sponsor: Fudan University

Brief Summary

Establishment and validation of the deep learning signature of bevacizumab efficacy in initially unresectable CRLM patients

Detailed Description

Initially unresectable CRLM patients were included in this study. The tumor response was assessed by local MDT group. The signature will classified patients into responder or non-responder group. We will administer mFOLFOX6+bevacizumab regimen to responders, and FOLFOXIRI regimen to non-responders.

Study Timeline

• Study First Submitted: 2022-04-26
• Study First Submitted QC: 2022-04-26
• Study First Posted: 2022-04-29
• Status Verified: 2023-01
• Last Update Submitted: 2023-07-12
• Last Update Posted: 2023-07-13
• Study Start: 2023-09-01
• Primary Completion: 2025-07-01
• Study Completion: 2028-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 302

Inclusion Criteria

Age 18-75 years; Histologically proven colorectal adenocarcinoma; Simultaneous liver-limited metastases; Initially unresectable liver metastases determined by a local MDT; Life expectancy of > 3 months; RAS mutation and BRAF V600E wild-type; ECOG 0-1; Available PET/CT imaging before treatment; Available colonoscopy biopsy specimens before treatment

Exclusion Criteria

Previous systemic treatment for metastatic disease; Previous surgery for metastatic disease; Extrahepatic metastases; Unresectable primary tumor; Major cardiovascular events (myocardial infarction, severe/unstable angina, congestive heart failure, CVA) within 12 months before randomisation; Acute or subacute intestinal obstruction; Second primary malignancy within the past 5 years; Drug or alcohol abuse; No legal capacity or limited legal capacity; Pregnant or lactating women; Uncontrolled hypertension, or unsatisfactory blood pressure control with ≥3 antihypertensive drugs; Peripheral neuropathy;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ARM A	Bevacizumab	Chemotherapy regimens are determined based on the clinical experience of specialists
ARM B	Bevacizumab	Chemotherapy regimens are determined based on the multimodal deep learning signature

Primary Outcome Measures

Name	Time	Method
response rate	6 months	response rate will be assessed by local MDT every two months
progression free survival	3 years	progression free survival will be assessed by local MDT every two months during

Secondary Outcome Measures

Name	Time	Method
overall survival	5 years	overall survival will be assessed by researchers every two months during treatment, and telephone follow-up every three month after treatment

Trial Locations

Locations (1)

Zhongshan hospital; 🇨🇳 Shanghai, Shanghai, China