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

NCT04417010 | Unknown

• 1 other identifier: 2020-2-2152
• Study Type: observational
• Target: 163
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Radiofrequency ablation PROCEDURE

Both groups of patients underwent radiofrequency ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Men or women 18 years of age or older

You may qualify if:

• 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-

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director

Study Record Dates

• First Submitted: June 2, 2020
• First Posted: June 4, 2020
• Study Start: June 1, 2020
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: June 9, 2020

Record last verified: 2020-06