The Role and Safety of Radiofrequency Ablation in Recurrent Liver Metastasis of Colorectal Cancer

Launched by PEKING UNIVERSITY CANCER HOSPITAL & INSTITUTE · Sep 22, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a treatment called radiofrequency ablation for patients with recurrent colorectal cancer that has spread to the liver. The main goal is to find out if this treatment is safe and effective, especially when combined with other therapies. Researchers want to see if using radiofrequency ablation can help patients live longer and how well it works compared to just using medication.

To participate in the trial, patients need to be adults aged 18 or older who have had their initial colorectal cancer surgery and have multiple small tumors in their liver that can be treated with radiofrequency ablation. Participants will receive regular check-ups at the hospital every three months to monitor their health and treatment progress. It’s important for those interested to know that this trial is not yet recruiting participants, but it aims to provide valuable information about a potentially helpful treatment for liver metastases in colorectal cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients with colorectal cancer whose primary lesions have been resected or can be controlled;
• • 2. Multiple confined lesions in the liver, the number of which can be defined;
• • 3. The liver contains at least 2 lesions suitable for radiofrequency ablation;
• • 4. The maximum diameter of the intrahepatic tumor is \<5 cm;
• • 5. The location of the hepatic lesion does not show obvious invasion with neighboring organs or large blood vessels;
• • 6. No extrahepatic metastases or stable extrahepatic metastases;
• • 7. Re-operative hepatic surgical resection is not indicated or refused;
• • 8. Ultrasound or ultrasonography can show intrahepatic lesions;
• • 9. The patient and his/her family request active treatment;
• • 10. Voluntary informed consent;
• • 11. Male or female at least 18 years of age;
• • 12. Platelet count \>50, 000/mm3 and prothrombin activity \>50%;
• • 13. Subjects are willing to return to the study center for study follow-up;
• • 14. Life expectancy ≥ 6 months.
• Exclusion Criteria:
• • 1. Suffering from, but not limited to, the following serious illnesses: congestive heart failure, myocardial infarction or cerebrovascular accident, or life-threatening cardiac arrhythmia within the last 6 months;
• • 2. Pregnancy or lactation. Women of childbearing potential must have a negative serum pregnancy test prior to receiving study treatment;
• • 3. Known hypersensitivity to any of the intravenous imaging agents that will be used in the study;
• • 4. Have portal or hepatic vein tumor infiltration/cancer embolism;
• • 5. Prothrombinogen international normalized ratio \>1.5 times the upper limit of normal (UNL) at the study center;
• • 6. Platelet count \<50, 000/mm3, absolute neutrophil count \<1500/mm3, or hemoglobin value \<10.0 g/dL;
• • 7. Serum creatinine ≥ 2.5 mg/dL or calculated creatinine clearance (CrCl) ≤ 25.0 ml/min;
• • 8. Serum bilirubin \>3.0 mg/dL;
• • 9. Serum albumin \<2.8 g/dL;
• • 10. Body temperature \>101°F (38.3°C) immediately prior to study treatment;
• • 11. Being treated with other investigational drugs;
• • 12. Heart failure NYHA functional class III or IV.
• • 13. Any other circumstances that the investigator deems inappropriate for enrollment.