Multimodal Deep Learning Signature for Evaluation of Response to Bevacizumab in Patient With Colorectal Cancer Liver Metastasis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bevacizumab.
- Who it may be relevant to
- Registry conditions: Colorectal Cancer, Liver Metastases. Basic parameters: 18 years — 79 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Drug Bevacizumab
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
Primary outcome measures
- response rate [Time frame: 6 months]
- progression free survival [Time frame: 3 years]
Secondary outcome measures (1)
- overall survival [Time frame: 5 years]
Eligibility 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; 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;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Zhongshan hospital — Shanghai
Identifiers
NCT: NCT05354674 · CRC-MULTIMODAL-01 RESEARCH