Liver transplantation for patients with colorectal cancer that has spread to the liver
Colorectal Metastasis and Liver Transplantation With Organs From Deceased Donors: an Inductive Padova Center Protocol
This study is testing if liver transplants can help people with colorectal cancer that has spread to the liver live longer compared to those who only receive chemotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Azienda Ospedaliera di Padova Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Padova) |
| Trial ID | NCT04870879 on ClinicalTrials.gov |
What this trial studies
The MELODIC trial is a multicenter, non-randomized, open-label trial designed to evaluate the effectiveness of liver transplantation in patients with unresectable colorectal liver metastases. It compares the overall survival of these patients receiving liver transplants to a matched cohort undergoing chemotherapy. Participants must meet specific inclusion criteria, including age, performance status, and tumor characteristics, and must have undergone prior surgical resection of the primary tumor. The study aims to provide insights into the potential benefits of liver transplantation for this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with histologically confirmed colorectal adenocarcinoma and liver metastases that are not eligible for curative resection.
Not a fit: Patients with extrahepatic metastatic disease or those who do not meet the specific inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates for patients with unresectable colorectal liver metastases.
How similar studies have performed: While liver transplantation for colorectal metastases is a novel approach, similar studies have shown promising results in select patient populations.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Padova
- U.O.C Chirurgia Epatobiliare e Trapianti Epatici, Azienda Ospedaliera di Padova — Padova, Italy (Recruiting)
Study contacts
- Principal investigator: Umberto Cillo, MD — U.O.C Chirurgia Epatobiliare e dei Trapianti Epatici, AOPD
- Study coordinator: Umberto Cillo, MD
- Email: cillo@unipd.it
- Phone: 049.8212211-1897
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.