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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Cancer; Liver Metastases
• Intervention / Treatment: Drug: Bevacizumab

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 Type: Observational
• Enrollment (Estimated): 302

Contacts and Locations

• Study Contact: Name: Jianmin Xu, Dr.; Phone Number: +86-021-64041990; Email: xujmin@aliyun.com
• Study Contact Backup: Name: Wenju Chang, Dr.; Phone Number: +86-021-64041990; Email: chang.wenju@zs-hospital.sh.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Zhongshan Hospital
      • Contact: Jianmin Xu, Dr.; Phone Number: +86-216-4041990; Email: xujmin@aliyun.com
      • Contact: Wenju Chang, Dr.; Phone Number: +86-216-4041990; Email: chang.wenju@zs-hospital.sh.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Initially unresectable CRLM patients with PET/CT images and colonoscopy biopsy specimens before treatment.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ARM A; Chemotherapy regimens are determined based on the clinical experience of specialists	Drug: Bevacizumab; AEM A：The specialist's decision to add bevacizumab to chemotherapy will be based on their own judgment ARM B：The patient's PET/CT imaging, pathology, and clinical information were input into the signature, and the FOLFOX+Bevacizumab regimen was selected when the output label was 1. FOLFOXIRI chemotherapy regimen was selected when the output label was 0
ARM B; Chemotherapy regimens are determined based on the multimodal deep learning signature	Drug: Bevacizumab; AEM A：The specialist's decision to add bevacizumab to chemotherapy will be based on their own judgment ARM B：The patient's PET/CT imaging, pathology, and clinical information were input into the signature, and the FOLFOX+Bevacizumab regimen was selected when the output label was 1. FOLFOXIRI chemotherapy regimen was selected when the output label was 0

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
response rate	response rate will be assessed by local MDT every two months	6 months
progression free survival	progression free survival will be assessed by local MDT every two months during	3 years

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
progression free survival	progression free survival will be assessed by local MDT every two months during treatment, and telephone follow-up every three month after treatment	3 years

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2023
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: April 26, 2022
• First Submitted That Met QC Criteria: April 26, 2022
• First Posted (Actual): April 29, 2022

Study Record Updates

• Last Update Posted (Actual): July 13, 2023
• Last Update Submitted That Met QC Criteria: July 12, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: bevacizumab; radiomics; multimodal; colorectal cancer liver metastasis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Liver Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Neoplastic Processes; Colorectal Neoplasms; Neoplasm Metastasis; Liver Neoplasms; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Bevacizumab
• Other Study ID Numbers: CRC-MULTIMODAL-01 RESEARCH

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No