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Establishment and validation of the deep learning signature of bevacizumab efficacy in initially unresectable CRLM patients
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | overall survival will be assessed by researchers every two months during treatment, and telephone follow-up every three month after treatment | 5 years |
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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;
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Initially unresectable CRLM patients with PET/CT images and colonoscopy biopsy specimens before treatment.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianmin Xu, Dr. | Contact | +86-021-64041990 | xujmin@aliyun.com | |
| Wenju Chang, Dr. | Contact | +86-021-64041990 | chang.wenju@zs-hospital.sh.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan hospital | Shanghai | Shanghai Municipality | 200032 | China |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |