Clinical trial · Observational
Liver Transplantation in Patients With Unresectable Colorectal Liver Metastases
NCT04616495CI-TRIAL-00069859TRASMETIRrecruitingClinicalTrials.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)
Multicentric prospective and observational study to assess the 5-year overall survival in a cohort of patients with unresectable liver-only colorectal metastases, well controlled by chemotherapy prior to liver transplantation.
Conditions
Conditions (3)
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 Metastases | — | UNRESOLVED | — |
| Metastatic Liver Cancer | Malignant Liver Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Liver transplantation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Liver transplanted patients
- interventionNames
- Procedure: Liver transplantation
Primary outcomes (1)
- measure
- five year overall survival (OS)
- timeFrame
- 5 years
Secondary outcomes (6)
- measure
- one year disease free survival (DFS)
- timeFrame
- 1 year
- measure
- three year disease free survival (DFS)
- timeFrame
- 3 years
- measure
- five year disease free survival (DFS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * ≥ 18 and ≤ years * Good performance status, ECOG 0 or 1 * Resected adenocarcinoma in colon or rectum (R0 resection) * Unresectable liver metastases * No extrahepatic disease * Normal blood tests * Response to ≤ 2 lines of chemotherapy (RECIST criteria) * ≥ 1 year period since diagnosis of colorectal cancer to enrolment in liver transplant waiting list * Signed informed consent Exclusion Criteria: * Body mass index ≥ 30 * Positive HIV or HCV * Pregnancy at the time of inclusion * BRAF mutated status * Deterioration of general condition (10% weight loss in the prior 6 months) * Other malignancy with disease free survival \< 5 years * Concomitant or prior extrahepatic metastases (histologically or radiologically proved), even if surgically resected. * Palliative resection of primary colorectal adenocarcinoma * Liver metastases size \> 5 cm (in the last imaging technique) * CEA \> 80 ng/ml (at time of enrolment in waiting list) * No neoadjuvant chemotherapy treatment * General contraindication to liver transplantation
References
Publications (0)
Data not yet available
No reference posted for this study.