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

Sponsor

Fudan University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05873972

Collaborator

(none)

100

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

2.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer Liver Metastases	Drug: Cetuximab	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

response rate [6 months]
response rate will be assessed by local MDT

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 > 6 months;
RAS and BRAF V600E wild-type;
ECOG 0-1;
Available CT imaging 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;
Uncontrolled hypertension, or unsatisfactory blood pressure control with ≥3 antihypertensive drugs;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhongshan Hospital, Fudan University	Shanghai	Shanghai	China	200032
2	Zhongshan hosptial, Fudan University	Shanghai		China	200032

Sponsors and Collaborators

Fudan University

Investigators

Principal Investigator: Jianmin Xu, MD, Fudan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Xu jianmin, Head of Colorectal Surgery, Fudan University

ClinicalTrials.gov Identifier:

NCT05873972

Other Study ID Numbers:

CRC-MULTIMODAL-02 RESEARCH

First Posted:

May 24, 2023

Last Update Posted:

May 24, 2023

Last Verified:

Jun 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of May 24, 2023