Local Immunomodulation After Radiofrequency of Unresectable Colorectal Liver Metastases (NCT04062721) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Local Immunomodulation After Radiofrequency of Unresectable Colorectal Liver Metastases
France12 participantsStarted 2025-08
Plain-language summary
The main objective of this trial is to determine feasibility and tolerance of the human body to RFA associated with local immunomodulation carried out using a thermoreversible hydrogel combined with 2 immunomodulators, GMCSF and Mifamurtide.
The main endpoint of the study is the feasibility, the frequency and the nature of per and post-operative adverse events of the in situ injection of an immunomodulatory hydrogel after radiofrequency of unresectable colorectal liver metastases.
The secondary objective is one-year progression free survival rate.
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
. Written informed consent obtained from the patient prior to performing any protocol-related procedures, including screening evaluations;
. Willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up;
. Histologically or cytologically proven CRC;
. Non-resectable liver metastases from CRC without detectable extra-hepatic disease, on abdomino-pelvic computed tomography (CT) or magnetic resonance imaging (MRI) and chest CT by the consulting hepatobiliary surgeon and radiologist. Unresectability is defined as no possibility to completely resect all tumor lesions;
. Age ≥ 18 years;
. ECOG PS 0-1;
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.
. Controlled disease (stability or objective response) with chemotherapy (≥ 2 months) for liver metastases;
. Liver metastases ≥ 3 and \<10, including ≥ 3 lesions accessible to RFA;
Exclusion criteria
. Any other malignancy in the past 10 years (except carcinoma of the cervix in situ or no melanoma skin cancer);
. Clinical significant cardiovascular disease;
. Uncontrolled hypertension, bleeding disorders or coagulopathy, active infection;
. Major surgical procedures within 28 days before RFA;
. Concurrent enrolment in another clinical study, unless it is an observational (noninterventional) or supportive care clinical study or during the follow-up period of an interventional study;
. Receipt of the last dose of anticancer therapy (investigational product, chemotherapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies) ≤ 21 days prior to the RFA. If sufficient wash-out time has not occurred due to the schedule or pharmacokinetics properties of an agent, a longer wash-out period will be required;
. Histology other than adenocarcinoma;
. Extensive tumor massively replacing both entire lobes;