Status:
UNKNOWN
To Identify KRAS Gene and Safe Margin in Association With Outcome in Colorectal Liver Metastases Following Ultrasound-guided Radiofrequency Ablation
Lead Sponsor:
Peking University Cancer Hospital & Institute
Conditions:
KRAS Gene
Colorectal Cancer
Eligibility:
All Genders
18+ years
Brief Summary
To investigate the clinical effect of radiofrequency ablation on colorectal cancer liver metastases with different KRAS gene status
Eligibility Criteria
Inclusion
- 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
- 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 .
Key Trial Info
Start Date :
June 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 31 2023
Estimated Enrollment :
163 Patients enrolled
Trial Details
Trial ID
NCT04417010
Start Date
June 1 2020
End Date
May 31 2023
Last Update
June 9 2020
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