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 range18 Years
SexALL
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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;
✓. Controlled disease (stability or objective response) with chemotherapy (≥ 2 months) for liver metastases;
✓. Liver metastases ≥ 3 and \<10, including ≥ 3 lesions accessible to RFA;
. 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;