Multimodal Deep Learning Signature for Evaluation of Response to Bevacizumab in Patient With Colorectal Cancer Liver Metastasis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 302
- 试验地点
- 1
- 主要终点
- response rate
研究概览
简要总结
Establishment and validation of the deep learning signature of bevacizumab efficacy in initially unresectable CRLM patients
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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;
研究组 & 干预措施
ARM A
Chemotherapy regimens are determined based on the clinical experience of specialists
干预措施: Bevacizumab (Drug)
ARM B
Chemotherapy regimens are determined based on the multimodal deep learning signature
干预措施: Bevacizumab (Drug)
结局指标
主要结局
response rate
时间窗: 6 months
response rate will be assessed by local MDT every two months
progression free survival
时间窗: 3 years
progression free survival will be assessed by local MDT every two months during
次要结局
- overall survival(5 years)
研究者
Xu jianmin
Head of Colorectal Surgery
Fudan University