Liver Transplantation for Unresectable Liver Limited Colorectal Metastases

Launched by WEILL MEDICAL COLLEGE OF CORNELL UNIVERSITY · Feb 3, 2021

Keywords

ClinConnect Summary

This clinical trial is exploring the possibility of using liver transplantation as a treatment for patients with liver-limited colorectal cancer that cannot be surgically removed. The study is being conducted at Weill Cornell Medical College and aims to gather important information about patient demographics, cancer characteristics, and outcomes after transplantation. Patients will be carefully screened by a team of specialists to determine if they meet specific criteria, such as having a confirmed diagnosis of colon or rectal cancer, showing no signs of cancer spread outside the liver, and having stable or shrinking liver tumors for at least six months.

To be eligible for this study, participants should be between 18 and 65 years old, in good overall health, and have received at least six months of chemotherapy. They should also have a specific level of a blood marker related to cancer and meet certain health requirements. If someone qualifies and decides to participate, they can expect close monitoring and support from the research team throughout the process. This trial is currently recruiting participants, so it may be a valuable opportunity for those facing challenges with their liver cancer treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Histologically confirmed adenocarcinoma of the colon or rectum
• • 2. No evidence of extrahepatic metastases or local recurrence based on PET/CT and colonoscopy
• • 3. No signs of extrahepatic metastases or local recurrence according to PET/CT 4 weeks prior to consideration of transplant
• • 4. Age 18-65 years old
• • 5. Good performance status with ECOG 0-1
• • 6. Stability or regression of liver metastasis for at least 6 months
• • 7. Minimum of 1 year between diagnosis of colon cancer and liver transplant and 6 months from primary tumor resection and liver transplant
• • 8. Minimum of 6 months chemotherapy
• • 9. CEA \< 200 ug/L 3 months prior to transplant
• • 10. Adequate organ and marrow function with Hb \> 10 g/dL, ANC \> 1000/uL, platelets \> 100,000/uL, bilirubin \< 2x ULN, AST/ALT \< 5x ULN, Creatinine \< 1.25 x ULN, Albumin above LLN
• Exclusion Criteria:
• • 1. Evidence of extrahepatic disease or local recurrence
• • 2. Previous resection of lung metastases
• • 3. MSI-H/dMMR or BRAF mutation
• • 4. Any other medical or co-morbid condition that would preclude liver transplantation, as determined by the transplant team