Colorectal Cancer Liver Metastases
Conditions
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.
Interventions
DRUGCetuximab
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
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| response rate | 6 months | response rate will be assessed by local MDT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary ContactJianmin Xu, MD
Backup ContactWenju Chang, MD
Outcome results
None listed