Living donor liver transplant for patients with non-resectable colorectal 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"]
This study is testing whether living donor liver transplants can help patients with colorectal cancer that has spread to the liver live longer and healthier lives.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years to 77 Years |
| Sex | All |
| Sponsor | Azienda Ospedaliero-Universitaria di Modena Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Modena, MO) |
| Trial ID | NCT05186116 on ClinicalTrials.gov |
What this trial studies
This interventional study evaluates the effectiveness of living donor liver transplantation (LDLT) in patients with unresectable colorectal liver metastases (CRLM). It aims to assess overall and disease-free survival rates, as well as graft survival and donor outcomes. Patients will undergo a thorough screening process to determine eligibility based on specific criteria related to their cancer status and overall health. The study will follow patients through pre-transplant screening and the transplantation process, ensuring adherence to established protocols.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed colon adenocarcinoma and liver metastases that are not eligible for surgical resection.
Not a fit: Patients with extrahepatic metastatic disease or those who do not meet the specific eligibility criteria will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a curative treatment option for patients with otherwise untreatable liver metastases from colorectal cancer.
How similar studies have performed: Previous studies have shown promising results with living donor liver transplantation in similar contexts, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Modena, MO
- Azienda Ospedaliero Universitaria di Modena — Modena, Mo, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.