Status:
NOT_YET_RECRUITING
Multimodal Deep Learning Signature for Evaluation of Response to Bevacizumab in Patient With Colorectal Cancer Liver Metastasis
Lead Sponsor:
Fudan University
Conditions:
Colorectal Cancer
Liver Metastases
Eligibility:
All Genders
18-79 years
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 w...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
September 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2028
Estimated Enrollment :
302 Patients enrolled
Trial Details
Trial ID
NCT05354674
Start Date
September 1 2023
End Date
July 1 2028
Last Update
July 13 2023
Active Locations (1)
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1
Zhongshan hospital
Shanghai, Shanghai Municipality, China, 200032