Colorectal Metastasis and Liver Transplantation With Organs From Deceased Donors (MELODIC)

University of Padua

Status: Enrolling

Conditions: Colorectal Liver Metastases; Colorectal Adenocarcinoma; Unresectable Malignant Neoplasm

Treatments: Procedure: Liver Transplant; Drug: Chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04870879

AOP1840

Details and patient eligibility

About

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"

Enrollment: 18 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

Study arm

Experimental group

Description:

Liver transplant

Treatment:

Procedure: Liver Transplant

Parallel arm

Other group

Description:

Chemotherapy

Treatment:

Drug: Chemotherapy