LDLT in Non Resectable Colo-rectal Cancer Liver Metastasis
Recruiting · NCT05186116 · Interventional (participants receive a specific treatment) · Lead sponsor: Azienda Ospedaliero-Universitaria di Modena
View the official record on ClinicalTrials.gov →Interventions studied
Living donor liver transplant, Split liver transplant, RAPID, DDLT
What this trial is about
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.
Who can take part
Age range
18 Years to 77 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
- 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.
- Performance status, ECOG (Eastern Cooperative Oncology Group) 0-2.
- Signed informed consent and expected cooperation of the patients for the treatment and follow-up, and national/local regulations.
Exclusion criteria
- 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)
- Active HIV infection
- Psychiatric disorders and patient low compliance
- Any reason why, in the judgment of the investigators, the patient should not participate (to be formally declared)
Where it is running
1 location listed.
- Azienda Ospedaliero Universitaria di Modena - Modena, MO, Italy