Clinical trial · Interventional
Colorectal Metastasis and Liver Transplantation With Organs From Deceased Donors
Colorectal Metastasis and Liver Transplantation With Organs From Deceased Donors: an Inductive Padova Center Protocol
- 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)
MELODIC trial is an prospective, multicenter, non-randomized, open-label, parallel trial, aimed at assessing the efficacy (in terms of overall survival: OS) of liver transplantation (LT) in unresecable CRC liver-only metastases, compared with a matched cohort of patients bearing the same tumor characteristics, and treated with chemotherapy. Synthesis of Inclusion parameters: "10;10;10;100"
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 Adenocarcinoma | Colorectal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Colorectal Liver Metastases | — | UNRESOLVED | — |
| Unresectable Malignant Neoplasm | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy | Drug | Chemotherapy | ALIAS |
| Liver Transplant | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Study arm
- description
- Liver transplant
- interventionNames
- Procedure: Liver Transplant
- type
- OTHER
- label
- Parallel arm
- description
- Chemotherapy
- interventionNames
- Drug: Chemotherapy
Primary outcomes (2)
- measure
- Overall survival
- timeFrame
- 3 years
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria (Sythesis: 10;10;10;100): * ≥ 18 and \<70 years * Performance status, ECOG 0-1 * 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 tumor * Liver metastases not eligible for curative liver resection confirmed by the validation committee * At least one line (3 months) of chemotherapy * No signs of extra hepatic metastatic disease or local recurrence on CT, MRI and Pet-CT within 4 weeks prior to the faculty meeting at the transplant unit * Before start of chemotherapy no lesion should be larger than \> 10 cm * Objective response according to RECIST 1.1 or SD at two consecutive CT without CEA increase * Patient with less than 10% response on chemotherapy may be included if they obtain al least 20% response after TACE (DEB-IRI) or by 90Y-spheres * At least 10 months time span from CRC resection and date of being listed on the transplantation list. * Satisfactory blood tests Hb \>10g/dL, neutrophils \>1.0, Bilirubin\<2 x upper normal level, AST, ALT\<5 x upper normal level, creatinine and albumin in normal level. * CEA\<100 ng/ml * Signed informed consent and expected cooperation of the patients for the treatment and follow up Exclusion Criteria: * Weight loss \>10% the last 6 months * Patient BMI \> 30 * Participation refusal * General contraindication to LT * Prior extra hepatic metastatic disease or primary tumor local relapse. * Other malignancies in the previous 5 years * Pregnancy or breast feeding * Any reason why, in the opinion of the investigator, the patient should not participate.
References
Publications (0)
Data not yet available