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

Not Applicable

Not yet recruiting

• Conditions: Colorectal Cancer Liver Metastases
• Interventions: Drug: Cetuximab

• Registration Number: NCT05873972
• Lead Sponsor: Fudan University

Brief Summary

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

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 Timeline

• Status Verified: 2022-06
• Study First Submitted: 2023-02-17
• Study First Submitted QC: 2023-05-22
• Last Update Submitted: 2023-05-22
• Study First Posted: 2023-05-24
• Last Update Posted: 2023-05-24
• Study Start: 2023-06-01
• Primary Completion: 2024-06-01
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ARM A	Cetuximab	Chemotherapy regimens are determined based on the clinical experience of specialists
ARM B	Cetuximab	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

Secondary Outcome Measures

Name	Time	Method
progression free survival	3 years	progression free survival will be assessed by local MDT every two months during treatment, and telephone follow-up every three month after treatment
overall survival	3 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 (2)

Zhongshan hosptial, Fudan University; 🇨🇳 Shanghai, China

Zhongshan Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China