Multimodal Model for Efficacy Prediction Cetuximab in Colorectal Cancer Liver Metastasis Patient

Multimodal Deep Learning Radiomic Nomogram for Evaluation of Response to Cetuximab in Patient With Colorectal Cancer Liver Metastasis

Establishment and validation of the deep learning model of Cetuximab efficacy in simultaneous RAS wild unresectable CRLM patients

Study Overview

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

Detailed Description

Ras wild unresectable CRLM patients with primary tumor resection followed by Cetuximab in combination with chemotherapy were included in this study. The tumor response was assessed by local MDT group. Based on tumor response, almost 100 CRLM patients were classified into two groups (Clinician drived regimen vs Multi-omics model drived regimen). They will be the prospective cohort to validate our deep learning model for predicting Cetuximab efficacy.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

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

Study Locations

• China
  • Shanghai, China, 200032
    • Zhongshan hosptial, Fudan University
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Zhongshan Hospital, Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 18-75 years;
2. Histologically proven colorectal adenocarcinoma;
3. Simultaneous liver-limited metastases;
4. Initially unresectable liver metastases determined by a local MDT;
5. Life expectancy of > 6 months;
6. RAS and BRAF V600E wild-type;
7. ECOG 0-1;
8. Available CT imaging before treatment.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ARM A; Chemotherapy regimens are determined based on the clinical experience of specialists	Drug: Cetuximab; AEM A：The specialist's decision to add cetuximab to chemotherapy will be based on their own judgment ARM B：The patient's CT imaging,genetic mutation information were input into the signature, and the FOLFOX+cetuximab regimen was selected when the output label was 1. FOLFOX+bevacizumab chemotherapy regimen was selected when the output label was 0
Experimental: ARM B; Chemotherapy regimens are determined based on the multimodal deep learning signature	Drug: Cetuximab; AEM A：The specialist's decision to add cetuximab to chemotherapy will be based on their own judgment ARM B：The patient's CT imaging,genetic mutation information were input into the signature, and the FOLFOX+cetuximab regimen was selected when the output label was 1. FOLFOX+bevacizumab 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	6 months

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	3 years
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
• Investigators: Principal Investigator: Jianmin Xu, MD, Fudan University

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2023
• Primary Completion (Anticipated): June 1, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: February 17, 2023
• First Submitted That Met QC Criteria: May 22, 2023
• First Posted (Actual): May 24, 2023

Study Record Updates

• Last Update Posted (Actual): May 24, 2023
• Last Update Submitted That Met QC Criteria: May 22, 2023
• Last Verified: June 1, 2022

More Information

Terms related to this study

• 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; Antineoplastic Agents; Antineoplastic Agents, Immunological; Cetuximab
• Other Study ID Numbers: CRC-MULTIMODAL-02 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