To Identify KRAS Gene and Safe Margin in Association With Outcome in Colorectal Liver Metastases Following Ultrasound-guided Radiofrequency Ablation

Study Overview
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Brief Summary
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To investigate the clinical effect of radiofrequency ablation on colorectal cancer liver metastases with different KRAS gene status

Official Title
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A Prospective Study to Identify KRAS Gene and Safe Margin in Association With Outcome in Colorectal Liver Metastases Following Ultrasound-guided Radiofrequency Ablation

Conditions
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KRAS Gene, Colorectal Cancer, Liver Metastasis, Safe Margin, Radiofrequency Ablation

Intervention / Treatment
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* Procedure: Radiofrequency ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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- Exclusion Criteria: 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 .

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Radiofrequency ablation|Both groups of patients underwent radiofrequency ablation|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| local tumor progression | 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 | 2020-06-01-2023-05-31 |