The Role and Safety of Radiofrequency Ablation in Recurrent Liver Metastasis of Colorectal Cancer (NCT06609434) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The Role and Safety of Radiofrequency Ablation in Recurrent Liver Metastasis of Colorectal Cancer
111 participantsStarted 2024-10
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients with colorectal cancer whose primary lesions have been resected or can be controlled;
. Multiple confined lesions in the liver, the number of which can be defined;
. The liver contains at least 2 lesions suitable for radiofrequency ablation;
. The maximum diameter of the intrahepatic tumor is \<5 cm;
. The location of the hepatic lesion does not show obvious invasion with neighboring organs or large blood vessels;
. No extrahepatic metastases or stable extrahepatic metastases;
. Re-operative hepatic surgical resection is not indicated or refused;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
liver progression-free survival
Timeframe: 2 years
Trial details
NCT IDNCT06609434
SponsorPeking University Cancer Hospital & Institute
. Ultrasound or ultrasonography can show intrahepatic lesions;
Exclusion criteria
. 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;
. Pregnancy or lactation. Women of childbearing potential must have a negative serum pregnancy test prior to receiving study treatment;
. Known hypersensitivity to any of the intravenous imaging agents that will be used in the study;
. Have portal or hepatic vein tumor infiltration/cancer embolism;
. Prothrombinogen international normalized ratio \>1.5 times the upper limit of normal (UNL) at the study center;
. Platelet count \<50, 000/mm3, absolute neutrophil count \<1500/mm3, or hemoglobin value \<10.0 g/dL;