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

• Conditions: Liver Metastasis; Radiofrequency Ablation; Colorectal Cancer; Safe Margin; KRAS Gene

• Registration Number: NCT04417010
• Lead Sponsor: Peking University Cancer Hospital & Institute

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-06
• Study Start: 2020-06-01
• Study First Submitted: 2020-06-02
• Study First Submitted QC: 2020-06-02
• Study First Posted: 2020-06-04
• Last Update Submitted: 2020-06-04
• Last Update Posted: 2020-06-09
• Primary Completion: 2023-05-31
• Study Completion: 2023-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 163

Inclusion Criteria

1. Diagnosed as liver metastasis of colorectal cancer;
2. 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;
3. The primary lesion of colorectal cancer has been treated curatively or is planned to undergo curative treatment;
4. KRAS gene test results can be obtained for primary or metastatic foci;
5. Signing informed consent voluntarily;
6. Men or women who have reached the age of 18;
7. Ultrasound or ultrasound contrast can clearly show the lesion and guide RFA treatment;
8. Platelet count> 50,000/mm3, prothrombin activity> 50%;
9. Child-Pugh grade A or B of liver disease, but no hepatic encephalopathy or/and ascites;
10. Subjects are willing to return to the research center for research follow-up;
11. Life expectancy ≥ 6 months-

Exclusion Criteria

1. 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;
2. During pregnancy or lactation. Before receiving research treatment, women of childbearing age must have a negative serum pregnancy test;
3. Any known allergic reactions to the intravenous imaging agent used in this study;
4. There is portal vein or hepatic vein tumor infiltration/carcinoma;
5. International normalized ratio of prothrombin> 1.5 times the upper limit of normal value (UNL) of the research center;
6. Platelet count <50,000/mm3, absolute neutrophil count <1500/mm3, or heme value <10.0g/dL;
7. Serum creatinine ≥2.5mg/dL or calculated creatinine clearance (CrCl) ≤25.0ml/min;
8. Serum bilirubin>3.0mg/dL;
9. Serum albumin <2.8g/dL;
10. Body temperature >101°F (38.3°C) immediately before study treatment;
11. being treated with other research drugs;
12. Heart failure NYHA function grade is III or IV .

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
local tumor progression	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