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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Cancer; Radiofrequency Ablation; Liver Metastasis; KRAS Gene; Safe Margin
• Intervention / Treatment: Procedure: Radiofrequency ablation

• Study Type: Observational
• Enrollment (Anticipated): 163

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Men or women 18 years of age or older

Description

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 Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Peking University Cancer Hospital & Institute

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2020
• Primary Completion (Anticipated): May 31, 2023
• Study Completion (Anticipated): May 31, 2023

Study Registration Dates

• First Submitted: June 2, 2020
• First Submitted That Met QC Criteria: June 2, 2020
• First Posted (Actual): June 4, 2020

Study Record Updates

• Last Update Posted (Actual): June 9, 2020
• Last Update Submitted That Met QC Criteria: June 4, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Liver Diseases; Neoplastic Processes; Neoplasm Metastasis; Liver Neoplasms
• Other Study ID Numbers: 2020-2-2152

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No