Colorectal Metastasis and Liver Transplantation With Organs From Deceased Donors

Launched by AZIENDA OSPEDALIERA DI PADOVA · Apr 28, 2021

Keywords

ClinConnect Summary

The MELODIC trial is a research study looking at whether liver transplantation can help patients with liver metastases from colorectal cancer when surgery isn't an option. The goal is to see if patients who receive a liver transplant have better overall survival compared to those who are treated with chemotherapy alone. This trial is currently recruiting participants aged 18 to 70 who have a specific type of colorectal cancer that has spread to the liver but hasn't spread elsewhere in the body.

To be eligible for the trial, participants need to have a confirmed diagnosis of colorectal adenocarcinoma, have undergone surgery to remove the primary tumor, and have already received at least three months of chemotherapy. They should not have any signs of cancer spread outside the liver or significant weight loss recently. If you or someone you know meets these criteria and is interested in participating, they can expect close monitoring and support throughout the trial, along with the opportunity to contribute to important research in cancer treatment.

Gender

ALL

Eligibility 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.