Multimodal Deep Learning Radiomic Nomogram for Evaluation of Response to Cetuximab 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
- 100
- 试验地点
- 2
- 主要终点
- response rate
研究概览
简要总结
Establishment and validation of the deep learning model of Cetuximab efficacy in simultaneous RAS wild unresectable CRLM patients
详细描述
Ras wild unresectable CRLM patients with primary tumor resection followed by Cetuximab in combination with chemotherapy were included in this study. The tumor response was assessed by local MDT group. Based on tumor response, almost 100 CRLM patients were classified into two groups (Clinician drived regimen vs Multi-omics model drived regimen). They will be the prospective cohort to validate our deep learning model for predicting Cetuximab efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 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 > 6 months;
- •RAS and BRAF V600E wild-type;
- •Available CT imaging 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;
- •Uncontrolled hypertension, or unsatisfactory blood pressure control with ≥3 antihypertensive drugs;
研究组 & 干预措施
ARM A
Chemotherapy regimens are determined based on the clinical experience of specialists
干预措施: Cetuximab (Drug)
ARM B
Chemotherapy regimens are determined based on the multimodal deep learning signature
干预措施: Cetuximab (Drug)
结局指标
主要结局
response rate
时间窗: 6 months
response rate will be assessed by local MDT
次要结局
- progression free survival(3 years)
- overall survival(3 years)
研究者
Xu jianmin
Head of Colorectal Surgery
Fudan University