Multimodal Deep Learning Radiomic Nomogram for Evaluation of Response to Bevacizumab in Patient With Colorectal Cancer Liver Metastasis
Study Details
Study Description
Brief Summary
Establishment and validation of the deep learning model of bevacizumab efficacy in simultaneous RAS mutant unresectable CRLM patients
Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
Ras mutant unresectable CRLM patients with primary tumor resection followed by bevacizumab in combination with chemotherapy were included in this study. The tumor response was assessed by local MDT group. Based on tumor response, almost 20 CRLM patients were classified into two groups (CR+PR vs SD+PD). They will be the external cohort to validate our deep learning model for predicting bevacizumab efficacy.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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External Validation Cohort
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Outcome Measures
Primary Outcome Measures
- response rate [6 months]
response rate will be assessed by local MDT every two months
Secondary Outcome Measures
- 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
Other 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
Eligibility Criteria
Criteria
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.
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;
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Zhongshan hospital | Shanghai | Shanghai | China | 200032 |
Sponsors and Collaborators
- Fudan University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CRC-MULTIMODAL-01 RESEARCH