NCT05186116
LDLT in Non Resectable Colo-rectal Cancer Liver Metastasis
Recruiting · Not Applicable · Azienda Ospedaliero-Universitaria di Modena · registry updated 2025-09-25
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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.
Inclusion
- 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.
- Liver metastases not eligible for curative liver resection
- Objective response according to RECIST 1.1 to first-line treatment, with sustained response for at least 4 months, OR disease control (complete \[CR\] or partial response \[PR\] or standard disease \[SD\]) during second- line treatment for at least 4 months.
- Carcinoembryonic Antigen (CEA) values stable or decreasing during the enrollment prior to liver transplant.
Exclusion
- 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
- Other malignancies in the previous 5 years (with exception of in situ cervical carcinoma and basal cell carcinoma; superficial bladder tumors are allowed if curatively treated).
- Active intra-venous or alcohol abusers (patients may be eligible if abstention \> 6 months is demonstrated)