Liver Transplantation in Patients With Unresectable Colorectal Liver Metastases

Launched by HOSPITAL UNIVERSITARIO LA FE · Nov 4, 2020

Keywords

ClinConnect Summary

This clinical trial is studying the possibility of performing liver transplants in patients who have colorectal cancer that has spread to the liver but cannot be surgically removed. The goal is to see how well patients do over five years after receiving a liver transplant, especially if their cancer has been well controlled by chemotherapy before the transplant. Researchers are looking for participants who are between 18 and 75 years old, have a good performance status (meaning they are generally healthy and can carry out daily activities), and have certain types of colorectal cancer with liver metastases that meet specific criteria.

To participate, individuals must have had a successful removal of their primary colorectal cancer, show no signs of cancer outside the liver, and have responded well to up to two rounds of chemotherapy. They should also have been diagnosed with colorectal cancer at least a year before joining the trial. Participants can expect to receive comprehensive care and monitoring throughout the study, and they will need to provide informed consent before taking part. It's important to note that there are some health conditions and factors that could exclude someone from joining the trial, such as having other active cancers or certain health issues. Overall, this research could provide valuable insights into the effectiveness of liver transplantation for patients with this specific type of cancer.

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Eligibility criteria

• Inclusion Criteria:
• • ≥ 18 and ≤ years
• • Good performance status, ECOG 0 or 1
• • Resected adenocarcinoma in colon or rectum (R0 resection)
• • Unresectable liver metastases
• • No extrahepatic disease
• • Normal blood tests
• • Response to ≤ 2 lines of chemotherapy (RECIST criteria)
• • ≥ 1 year period since diagnosis of colorectal cancer to enrolment in liver transplant waiting list
• • Signed informed consent
• Exclusion Criteria:
• • Body mass index ≥ 30
• • Positive HIV or HCV
• • Pregnancy at the time of inclusion
• • BRAF mutated status
• • Deterioration of general condition (10% weight loss in the prior 6 months)
• • Other malignancy with disease free survival \< 5 years
• • Concomitant or prior extrahepatic metastases (histologically or radiologically proved), even if surgically resected.
• • Palliative resection of primary colorectal adenocarcinoma
• • Liver metastases size \> 5 cm (in the last imaging technique)
• • CEA \> 80 ng/ml (at time of enrolment in waiting list)
• • No neoadjuvant chemotherapy treatment
• • General contraindication to liver transplantation