Clinical Research Directory

Yttrium-90 Radioembolization Neoadjuvant Therapy With Immune Marker Profiling and Dosimetry for Potentially Resectable Patients With Colorectal Liver Metastases

This is a observational, prospective, single arm, proof of concept study to assess safety, feasibility, and potential efficacy of combining Yttrium-90 transarterial radioembolization(TARE) with standard systemic therapy in clinical practice for potentially resectable patients with colorectal liver metastases (CRLM). Alternatively, resectability will also be evaluated. The investigators hypothesize that by applying this approach, higher local control and resection rates can be achieved (typically below 13% for patients who are initially deemed unresectable). Additionally, this treatment option is expected to help delay or reduce the need for (a switch in) systemic treatment and eventually improve survival in patients with liver metastases that are not resectable. All studies reporting the results of TARE at ablative doses are retrospective cohort studies or cases series. Prospective data is needed to expand the indications and reimbursement of radioembolization. Other objectives of the study are: * To calculate the resection rate in patients undergoing the combined approach. * To evaluate immune markers in peripheral blood and resected metastases. * To formulate the first concept of an algorithm, enable to deliver personalized AI assisted dosimetry. * To assess potential role of circulating tumor DNA (ctDNA) in evaluation of patient prognosis and follow up. * To determine the grade of necrosis at the time of resection and correlate with the absorbed dose.

Local Immunomodulation After Radiofrequency of Unresectable Colorectal Liver Metastases

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.