NCT04417010Unknown不适用
A Prospective Study to Identify KRAS Gene and Safe Margin in Association With Outcome in Colorectal Liver Metastases Following Ultrasound-guided Radiofrequency Ablation
Peking University Cancer Hospital & Institute0 个研究点目标入组 163 人开始时间: 2020年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 163
- 主要终点
- local tumor progression
研究概览
简要总结
To investigate the clinical effect of radiofrequency ablation on colorectal cancer liver metastases with different KRAS gene status
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed as liver metastasis of colorectal cancer;
- •There are no more than 3 liver metastases and all the lesions are not more than 5 cm; or no more than 6 liver metastases and all the lesions are not more than 3.0 cm;
- •The primary lesion of colorectal cancer has been treated curatively or is planned to undergo curative treatment;
- •KRAS gene test results can be obtained for primary or metastatic foci;
- •Signing informed consent voluntarily;
- •Men or women who have reached the age of 18;
- •Ultrasound or ultrasound contrast can clearly show the lesion and guide RFA treatment;
- •Platelet count> 50,000/mm3, prothrombin activity> 50%;
- •Child-Pugh grade A or B of liver disease, but no hepatic encephalopathy or/and ascites;
- •Subjects are willing to return to the research center for research follow-up;
- •Life expectancy ≥ 6 months-
排除标准
- •suffer from but not limited to the following serious diseases: congestive heart failure, myocardial infarction or cerebrovascular accident, or life-threatening arrhythmia in the past 6 months;
- •During pregnancy or lactation. Before receiving research treatment, women of childbearing age must have a negative serum pregnancy test;
- •Any known allergic reactions to the intravenous imaging agent used in this study;
- •There is portal vein or hepatic vein tumor infiltration/carcinoma;
- •International normalized ratio of prothrombin> 1.5 times the upper limit of normal value (UNL) of the research center;
- •Platelet count <50,000/mm3, absolute neutrophil count <1500/mm3, or heme value <10.0g/dL;
- •Serum creatinine ≥2.5mg/dL or calculated creatinine clearance (CrCl) ≤25.0ml/min;
- •Serum bilirubin>3.0mg/dL;
- •Serum albumin <2.8g/dL;
- •Body temperature >101°F (38.3°C) immediately before study treatment;
- •being treated with other research drugs;
- •Heart failure NYHA function grade is III or IV .
结局指标
主要结局
local tumor progression
时间窗: 2020-06-01-2023-05-31
the appearance of tumor foci at the edge of the ablation zones after at least one contrast-enhanced follow-up study has documented adequate ablation and covered by the ablation zone in the target tumor and surrounding ablation margin using imaging criteria
次要结局
未报告次要终点
研究者
Kun Yan
director
Peking University Cancer Hospital & Institute
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