Assessment of a Protocol Using a Combination of Neo-adjuvant Chemotherapy Plus Living Donor Liver Transplantation for Non-Resectable Liver Metastases From Colorectal Cancer
Patients with unresectable liver metastases (LM) from colorectal cancer (CRC)have a poor prognosis. In patients with resectable disease, surgery offers a distinct survival benefit. This study will offer live donor liver transplantation (LDLT) to select patients with unresectable metastases that are 1) limited to the liver and 2) stable (non-progressing) on standard chemotherapy. Potential participants will be evaluated for liver transplant suitability and must also have a willing, healthy living donor come forward for evaluation. Those participants who undergo LDLT will be followed for survival, disease-free survival and quality of life for 5 years and compared to a control group of participants who drop out of study prior to transplantation due to reasons other than cancer progression.
• Must reside in Canada
• ECOG ( Eastern Cooperative Oncology Group) score : 0-1 at all times prior to LDLT (excursions to ECOG 2 allowed at investigator's discretion)
• Proven colorectal Liver Metastases (LM).
• Willing and able to provide written informed consent.
• Negative serum pregnancy test for women of childbearing potential
• Both men and women must agree to use adequate barrier birth control measures during the course of the trial.
• At least 1 acceptable, ABO-compatible living donor has stepped forward
• Primary Colorectal cancer tumor stage is ≤T4a
• Time from primary CRC resection to transplant is ≥6 months
• Bilateral and non-resectable LM
• No major vascular invasion by LM; metastases isolated to liver
• The patient has undergone systemic chemotherapy (eg. FOLFOX +/- bevacizumab or FOLFIRI +/- bevacizumab) for ≥3 months
• demonstrated stability or regression of LM over at minimum the 3 months preceding screening
• Carcinoembryonic Antigen (CEA) values are stable or decreasing at all timepoints prior to the transplant surgery.