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Trial Title:
Multimodal Model for Efficacy Prediction Cetuximab in Colorectal Cancer Liver Metastasis Patient
NCT ID:
NCT05873972
Condition:
Colorectal Cancer Liver Metastases
Conditions: Official terms:
Colorectal Neoplasms
Neoplasm Metastasis
Liver Neoplasms
Cetuximab
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Cetuximab
Description:
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 group label:
ARM A
Arm group label:
ARM B
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.
Criteria for eligibility:
Criteria:
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;
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Zhongshan Hospital, Fudan University
Address:
City:
Shanghai
Zip:
200032
Country:
China
Facility:
Name:
Zhongshan hosptial, Fudan University
Address:
City:
Shanghai
Zip:
200032
Country:
China
Start date:
June 1, 2023
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05873972
