Clinical trial · Interventional
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"]
NCT05186116CI-TRIAL-00095754LIVERMORErecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Adenocarcinoma | Colon Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Liver Metastasis Colon Cancer | Colon Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Living donor liver transplant, Split liver transplant, RAPID, DDLT | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LDLT, partial graft, whole graft recipients
- description
- Patients that undergo LDLT, partial graft or whole graft transplantation for CRLM in the study period
- interventionNames
- Procedure: Living donor liver transplant, Split liver transplant, RAPID, DDLT
Primary outcomes (2)
- measure
- Overall survival
- timeFrame
- 5 years
- description
- Overall survival of patients treated with LDLT for unresectable CRLM compared to our historical cohort of potentially transplantable patients that underwent chemotherapy only
- measure
- Disease free survival
- timeFrame
- 5 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 77 Years
Show eligibility criteria text
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)
References
Publications (33)
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- RESULTCremolini C, Casagrande M, Loupakis F, Aprile G, Bergamo F, Masi G, Moretto R R, Pietrantonio F, Marmorino F, Zucchelli G, Tomasello G, Tonini G, Allegrini G, Granetto C, Ferrari L, Urbani L, Cillo U, Pilati P, Sensi E, Pellegrinelli A, Milione M, Fontanini G, Falcone A. Efficacy of FOLFOXIRI plus bevacizumab in liver-limited metastatic colorectal cancer: A pooled analysis of clinical studies by Gruppo Oncologico del Nord Ovest. Eur J Cancer. 2017 Mar;73:74-84. doi: 10.1016/j.ejca.2016.10.028. Epub 2016 Dec 13. PMID 27986363
- RESULTLang H, de Santibanes E, Schlitt HJ, Malago M, van Gulik T, Machado MA, Jovine E, Heinrich S, Ettorre GM, Chan A, Hernandez-Alejandro R, Robles Campos R, Sandstrom P, Linecker M, Clavien PA. 10th Anniversary of ALPPS-Lessons Learned and quo Vadis. Ann Surg. 2019 Jan;269(1):114-119. doi: 10.1097/SLA.0000000000002797. PMID 29727331
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