Multimodal Deep Learning Signature for Evaluation of Response to Bevacizumab in Patient With Colorectal Cancer Liver Metastasis
1 other identifier
observational
302
1 country
1
Brief Summary
Establishment and validation of the deep learning signature of bevacizumab efficacy in initially unresectable CRLM patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2023
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 26, 2022
CompletedFirst Posted
Study publicly available on registry
April 29, 2022
CompletedStudy Start
First participant enrolled
September 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2028
ExpectedJuly 13, 2023
January 1, 2023
1.8 years
April 26, 2022
July 12, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
response rate
response rate will be assessed by local MDT every two months
6 months
progression free survival
progression free survival will be assessed by local MDT every two months during
3 years
Secondary Outcomes (1)
overall survival
5 years
Study Arms (2)
ARM A
Chemotherapy regimens are determined based on the clinical experience of specialists
ARM B
Chemotherapy regimens are determined based on the multimodal deep learning signature
Interventions
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
Eligibility Criteria
Initially unresectable CRLM patients with PET/CT images and colonoscopy biopsy specimens before treatment.
You may qualify if:
- 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
You may not qualify if:
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fudan Universitylead
Study Sites (1)
Zhongshan hospital
Shanghai, Shanghai Municipality, 200032, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Colorectal Surgery
Study Record Dates
First Submitted
April 26, 2022
First Posted
April 29, 2022
Study Start
September 1, 2023
Primary Completion
July 1, 2025
Study Completion (Estimated)
July 1, 2028
Last Updated
July 13, 2023
Record last verified: 2023-01