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

Colorectal Cancer Liver Metastases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05873972
• Other study ID #: CRC-MULTIMODAL-02 RESEARCH
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2022
• Source: Fudan University
• Contact: Jianmin Xu, MD
• Phone: +86-021-64041990
• Email: xujmin[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Colorectal Cancer Liver Metastases
• Colorectal Neoplasms
• Liver Neoplasms
• Neoplasm Metastasis

Intervention

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

Locations

Country	Name	City	State
China	Zhongshan Hospital, Fudan University	Shanghai	Shanghai
China	Zhongshan hosptial, Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	response rate	response rate will be assessed by local MDT	6 months
Secondary	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
Secondary	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