Clinical trial · Interventional
Liver Transplantation for Non-Resectable Colorectal Liver Metastasis
- 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)
The study aims to evaluate the efficacy of liver transplantation in the context of non-resectable colorectal liver metastasis. The primary endpoint is the overall survival in this group of patients while the secondary endpoint is the disease-free survival. Patients included in this protocol will be evaluated either for whole or partial liver transplantation from deceased or living donors. Type of different transplantations proposed are as follows: 1. Whole liver graft or partial liver (split) from a deceased donor 2. Partial liver graft retrieved from a deceased donor and orthotopically implanted after having performed a left hepatectomy in the recipient. 3. Partial liver graft retrieved from a deceased donor and heterotopically implanted if total hepatectomy can not be performed. 4. Partial liver graft retrieved from a living donor and orthotopically implanted after having performed total hepatectomy. 5. Partial liver graft retrieved from a living donor and orthotopically implanted after having after having performed a left hepatectomy in the recipient. 6. Partial liver graft retrieved from a living donor and heterotopically implanted if total hepatectomy can not be performed. In cases 2-3-5-6 total hepatectomy of native liver can be secondarily performed after having achieved a proper graft hypertrophy in order to avoid a small for size syndrome
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 |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Liver Metastasis Colon Cancer | Colorectal Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Liver Transplantation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Liver Transplantation
- interventionNames
- Procedure: Liver Transplantation
Primary outcomes (1)
- measure
- Overall Survival
- timeFrame
- 5 years
Secondary outcomes (1)
- measure
- Disease-Free Survival
- timeFrame
- 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 73 Years
Show eligibility criteria text
Inclusion Criteria: * Primary tumor resected according to standard oncological practice, p≤T4a, R0 resection * Colorectal liver metastasis considered as non-resectable either up-front or after previous hepatic resections * No local recurrence of primary colon cancer confirmed by Positron Emission Tomography, Computed Tomography and colonoscopy * No extra-hepatic metastatic disease confirmed by Positron Emission Tomography and Computed Tomography * Good performance status Eastern Cooperative Oncology Group 0 or 1 * Neutrophils \> 1.000 * Patients who received at least one line of chemotherapy for at least 3 months with partial response or stable disease according to modified Response Evaluation Criteria in Solid Tumours * Carcino-Embryonic Antigen \< 80 µg/L or reduction of ≥ 50% of highest Carcino-Embryonic Antigen level observed * Written informed consent * No other contraindications to liver transplantation Exclusion Criteria: * Presence of other malignancies * Local recurrence of primary tumor * Extra-hepatic metastatic disease * Patients who did not receive any neoadjuvant or adjuvant therapy * Palliative resection of primary tumor * Any other reason, according to the investigators, that could be a contraindication to protocol enrollment
References
Publications (0)
Data not yet available