NCT05186116Recruiting
LDLT in Non Resectable Colo-rectal Cancer Liver Metastasis
Living Donor Liver Transplantation (LDLT) in Non Resectable Colo-rectal Cancer Liver Metastasis. The LIVERMORE Trial (LIVing Donor livEr tRansplant Modena cOloRectal mEtastasis) [Original Title in Italian: "Trapianto di Fegato da Donatore Vivente Per Metastasi Epatiche Non Resecabili da Adenocarcinoma Del Colon"]
Source: ClinicalTrials.gov · Last updated 25 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 25 (estimated)
- First submitted
- 24 Nov 2021
- Start date
- 1 Jan 2022
- Primary completion date
- 1 Jan 2027
- Lead sponsor
- Azienda Ospedaliero-Universitaria di Modena
- Diseases
- Colorectal cancer
- NCT number
- NCT05186116
What you commit to
- Study type: Interventional
- Planned participants: 25
- From 1 Jan 2022 to the primary completion date, 1 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior extra hepatic metastatic disease or primary tumor local relapse.
- Palliative resection of primary CRC tumor.
- 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).
Other illness
- Hereditary CRC syndromes including FAP (Familial adenomatous polyposis) and Lynch syndrome.
- Disease progression
- Active HIV infection
- Psychiatric disorders and patient low compliance
Other
- Active intra-venous or alcohol abusers (patients may be eligible if abstention \> 6 months is demonstrated)
- Any reason why, in the judgment of the investigators, the patient should not participate (to be formally declared)
Who the study is looking for
- 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.
Age in the registry: 18 years to 77 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Azienda Ospedaliero - Universitaria di Modena Coordinator of this site? Confirm its status | Modena | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.