Zhongshan hospital
Shanghai, Shanghai Municipality, 200032, China
Location contact
Jianmin Xu, Dr.
CONTACT
Wenju Chang, Dr.
CONTACT
NCT Number: NCT05354674
Establishment and validation of the deep learning signature of bevacizumab efficacy in initially unresectable CRLM patients
Trial opening soon.
Get Notified18 year–79 year
All sexes
Observational
Shanghai, Shanghai Municipality, 200032, China
Jianmin Xu, Dr.
CONTACT
Wenju Chang, Dr.
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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;
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
Time frame: 6 months
response rate will be assessed by local MDT every two months
Time frame: 3 years
progression free survival will be assessed by local MDT every two months during
Time frame: 5 years
overall survival will be assessed by researchers every two months during treatment, and telephone follow-up every three month after treatment
Contact information is provided by the study sponsor or research team.
Jianmin Xu, Dr.
CONTACT
Wenju Chang, Dr.
CONTACT
Fudan University
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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