Multimodal Deep Learning Signature for Evaluation of Response to Bevacizumab in Patient With Colorectal Cancer Liver Metastasis

Fudan University

Status

Not yet enrolling

Conditions

Liver Metastases

Colorectal Cancer

Treatments

Drug: Bevacizumab

Study type

Observational

Funder types

Other

Identifiers

NCT05354674

CRC-MULTIMODAL-01 RESEARCH

Details and patient eligibility

About

Establishment and validation of the deep learning signature of bevacizumab efficacy in initially unresectable CRLM patients

Full 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.

Enrollment

302 estimated patients

Sex

All

Ages

18 to 79 years old

Volunteers

No Healthy Volunteers

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;