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

NCT ID: NCT04417010

Last Updated: 2020-06-09

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 163 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2023-05-31

Brief Summary

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

Conditions

KRAS Gene; Colorectal Cancer; Liver Metastasis; Safe Margin; Radiofrequency Ablation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Radiofrequency ablation

Both groups of patients underwent radiofrequency ablation

Intervention Type: PROCEDURE

Eligibility Criteria

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 .

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Cancer Hospital & Institute

OTHER

Sponsor Role: lead

Responsible Party

Kun Yan

director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

2020-2-2152

Identifier Type: -

Identifier Source: org_study_id