LDLT in Non Resectable Colo-rectal Cancer Liver Metastasis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-77
SponsorAzienda Ospedaliero-Universitaria di Modena
About this trial
This study is an interventional open label prospective study that aims to assess both overall and disease-free survival of patients treated with LDLT, partial or whole graft LT from deceased donors for unresectable CRLM.
Secondary outcomes are graft survival and donor outcomes in terms of safety and quality of life.
Donor selection is performed according to the currently used Institutional and National standards and protocols.
Eligibility criteria
Qualifiers
Age ≥18.
Histologically confirmed colon and rectum (intraperitoneal) adenocarcinoma.
Pathological classification of primary tumor as pT1-3, without peritoneal tumor deposits, absence of mucinous component >50%, confirmed R0 resection, no limitations for RAS mutations, B-RAF wild type.
No signs of extra hepatic metastatic disease or local recurrence according to CT scan+MRI+PET/CT scans.
Disqualifiers
Hereditary CRC syndromes including FAP (Familial adenomatous polyposis) and Lynch syndrome.
Prior extra hepatic metastatic disease or primary tumor local relapse.
Palliative resection of primary CRC tumor.
Disease progression
Trial design
Treatments tested in this trial
- Living donor liver transplant, Split liver transplant, RAPID, DDLT
Treatment groups
25 Participants
are divided into 1 treatment groupLocations
1Azienda Ospedaliero Universitaria di Modena41124, ModenaMO, Italy
Sponsors and collaborators
Azienda Ospedaliero-Universitaria di Modena
Lead sponsor
Source ClinicalTrials.gov