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NCT06609434

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

Sponsor: Peking University Cancer Hospital & Institute

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to learn if radiofrequency ablation works to treat recurrent colorectal cancer liver metastases after surgery in adults. It will also learn about the safety of radiofrequency ablation. The main questions it aims to answer are: Is radiofrequency ablation safe and effective in the treatment of recurrent colorectal cancer liver metastases? What medical problems do participants have when treating with radiofrequency ablation? Does radiofrequency ablation enable patients with recurrent colorectal cancer liver metastases to live longer? Researchers will compare systemic therapy combined with radiofrequency ablation to systemic therapy to see if radiofrequency ablation works to treat liver metastases better. Participants will: Receive systemic treatment for colorectal cancer liver metastases. Undergo (or not) radiofrequency ablation for colorectal cancer liver metastases. Visit the hospital once every 3 months for checkups and tests.

Official title: The Role and Safety of Radiofrequency Ablation in the Multidisciplinary Treatment of Intrahepatic Recurrence After Colorectal Cancer Liver Metastasis Surgery

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

111

Start Date

2024-10

Completion Date

2026-12

Last Updated

2024-09-27

Healthy Volunteers

Conditions

Colo-rectal Cancer Liver Metastasis

Interventions

PROCEDURE

Radiofrequency ablation

This study is the first to apply radiofrequency ablation to multiple recurrent intrahepatic lesions of colorectal cancer liver metastases.

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.