Colorectal Cancer, Liver Metastases
Conditions
Keywords
colorectal cancer liver metastasis, bevacizumab, radiomics, multimodal
Brief summary
Establishment and validation of the deep learning signature of bevacizumab efficacy in initially unresectable CRLM patients
Detailed description
Initially unresectable CRLM patients were included in this study. The tumor response was assessed by local MDT group. The signature will classified patients into responder or non-responder group. We will administer mFOLFOX6+bevacizumab regimen to responders, and FOLFOXIRI regimen to non-responders.
Interventions
DRUGBevacizumab
AEM A：The specialist's decision to add bevacizumab to chemotherapy will be based on their own judgment ARM B：The patient's PET/CT imaging, pathology, and clinical information were input into the signature, and the FOLFOX+Bevacizumab regimen was selected when the output label was 1. FOLFOXIRI chemotherapy regimen was selected when the output label was 0
Sponsors
Fudan University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
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 \> 3 months; RAS mutation and BRAF V600E wild-type; ECOG 0-1; Available PET/CT imaging before treatment; Available colonoscopy biopsy specimens 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; Pregnant or lactating women; Uncontrolled hypertension, or unsatisfactory blood pressure control with ≥3 antihypertensive drugs; Peripheral neuropathy;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| response rate | 6 months | response rate will be assessed by local MDT every two months |
| progression free survival | 3 years | progression free survival will be assessed by local MDT every two months during |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| overall survival | 5 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, Dr.
Backup ContactWenju Chang, Dr.
Outcome results
None listed