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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04417010
• Other study ID #: 2020-2-2152
• Status: Not yet recruiting
• Start date: June 1, 2020
• Est. completion date: May 31, 2023

Study information

• Verified date: June 2020
• Source: Beijing Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 163
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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 .

Related Conditions & MeSH terms

• Colorectal Cancer
• KRAS Gene
• Liver Metastasis
• Liver Neoplasms
• Neoplasm Metastasis
• Radiofrequency Ablation
• Safe Margin

Intervention

Procedure:
• Radiofrequency ablation
Both groups of patients underwent radiofrequency ablation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Cancer Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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