Living Donor Liver Transplantation for Unresectable Colorectal Cancer Liver Metastases

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join if…

• 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.

🚫 You may not be able to join if…

• Previous or concurrent cancer (with some exceptions)
• prior lung resection
• Progression of LM at any timepoint prior to transplant surgery
• Renal dysfunction with an estimated creatinine clearance of less than 50 ml/min
• Pulmonary insufficiency
• History of cardiac disease
• Known history of human immunodeficiency virus (HIV) infection or chronic hepatitis B and/or C infection.
• Patients with debilitating neuropathy. (CTCAE > grade 2)
• BRAF + tumors
• Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study

Where this trial is running

• Toronto General Hospital, Toronto, Ontario, Canada

Who to contact

Erin Winter, BSc · 416-340-4800 · erin.winter@uhn.ca

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT02864485.