Colorectal Metastasis and Liver Transplantation With Organs From Deceased Donors

• Status: Recruiting
• Trial end date: 2025-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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"

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azienda Ospedaliera di Padova
• Collaborator: Istituto Oncologico Veneto IRCCS

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.