Clinical trial · Interventional
Liver Transplantation in Patients With Unresectable Colorectal Liver Metastases Treated by Chemotherapy
Curative Potential of Liver Transplantation in Patients With Definitively Unresectable Colorectal Liver Metastases (CLM) Treated by Chemotherapy: a Prospective Multicentric Randomized Trial
NCT02597348CI-TRIAL-00074030TRANSMETunknownN/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 is a multicentric randomized parallel group open trial comparing 5-year survival of chemotherapy followed by LT (Group LT+C) versus chemotherapy alone (Group C) in patients with confirmed unresectable liver-only metastases, well controlled by chemotherapy (no progression) and extensively explored by modern imaging techniques. The primary objective of the trial is to validate in a large multicentric cohort of selected patients the possibility to obtain at least 50% 5-years survival with LT combined to chemotherapy compared to around 10% with chemotherapy alone.
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 Metastasis | — | UNRESOLVED | — |
| Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Liver Transplantation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Liver Transplantation
- description
- Arm LT+C: patients will be treated by experimental liver transplantation preceding the non experimental standard chemotherapy (according to usual practices).
- interventionNames
- Procedure: Liver Transplantation
- type
- NO_INTERVENTION
- label
- No intervention
- description
- Arm C: patients will receive non experimental standard chemotherapy according to usual practices in the context of definitively unresectable CLM.
Primary outcomes (1)
- measure
- 5 years overall survival (OS)
- timeFrame
- 5 years
- description
- The evaluation of 5-years overall survival will be conducted by constructing survival curves using the Kaplan-Meier method. Graphs will be created following the best practices defined by Pocock. * If the proportionality of hazards is respected: Survival in each randomization arm will be compared using the Log-Rank test. The hazard ratio and the associated 95% confidence interval will be estimated using a Cox proportional hazards model. * If the proportionality of hazards is not respected: the difference in Restricted Mean Survival Time (RMST) between the arms and the associated 95% confidence interval will be estimated. The randomization stratification by cluster of centers will not be taken into account in the analyses. This is because it was done for administrative reasons.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * ≥ 18 and ≤ 65 years * Good performance status, ECOG 0 or 1 (39). * Histologically proved adenocarcinoma in colon or rectum * BRAF wild-type CRC on primary tumor or liver metastases * High standard oncological surgical resection of the primary defined by : * Safe margin of resection * Curative resection of primary tumor according to oncological principles * TNM adequate staging * Absence of local recurrence on colonoscopy performed in the 12 months prior to inclusion (except in case of primary tumor resection \< 12 months ) * Confirmed non resectable colorectal liver metastases by the validation committee * ≥ 3 months of tumor control during the last chemotherapy line: Stable or Partial Response on RECIST criteria (40) * ≤ 3 lines of chemotherapy for metastatic disease * CEA \< 80 microg/L or a decrease ≥ 50% of the highest serum CEA levels observed during the disease * Absence of extrahepatic tumor localisation according to CT scan and PET-CT * Renal function should be within the normal limits * No need for extra-renal purification procedure, hemodialysis or kidney transplantation associated (nephrologist assessment) * A platelet count\> 80,000 / mm3 * White blood cell count\> 2500 / mm3 * Eligible for both treatments groups * Signed informed consent and expected cooperation of the patient for the treatment and follow up Exclusion Criteria: * Participation refusal * No health insurance facilities * General contraindication to LT (Severe cardiopulmonary disease or other life-limiting coexisting medical conditions, extrahepatic malignancy, active alcohol or substance abuse, active infection or uncontrolled sepsis, lack of psychosocial support or inability to comply with medical treatment) * Other malignancies either concomitant or within 5 years before liver transplantation * Patients not having received standard treatment for the primary CRC according to recommended guidelines * Prior extra hepatic metastatic disease or local relapse * Pregnancy at the time of inclusion
References
Publications (1)
- DERIVEDAdam R, Piedvache C, Chiche L, Adam JP, Salame E, Bucur P, Cherqui D, Scatton O, Granger V, Ducreux M, Cillo U, Cauchy F, Mabrut JY, Verslype C, Coubeau L, Hardwigsen J, Boleslawski E, Muscari F, Jeddou H, Pezet D, Heyd B, Lucidi V, Geboes K, Lerut J, Majno P, Grimaldi L, Levi F, Lewin M, Gelli M; Collaborative TransMet group. Liver transplantation plus chemotherapy versus chemotherapy alone in patients with permanently unresectable colorectal liver metastases (TransMet): results from a multicentre, open-label, prospective, randomised controlled trial. Lancet. 2024 Sep 21;404(10458):1107-1118. doi: 10.1016/S0140-6736(24)01595-2. PMID 39306468