Liver Transplantation for Non-resectable Colorectal Liver Metastases: Translational Research

Prior treatment

• Largest Lesion \>5.5cm immediately prior to screening
• Recurrence of primary tumor confirmed by colonoscopy or pelvic MRI within the last 12 months prior to screening.
• Previous or concurrent cancer in the last 5 years. Any cancer curatively treated 5 years prior to entry or treated basal cell carcinoma is permitted.

Other illness

• Patients with Lynch Syndrome
• Substance abuse, medical, psychological or social conditions that may interfere with the patient´s participation in the study or evaluation of the study results.
• Cardiac or pulmonary disease uncontrolled as contraindication for any surgical procedure.
• Active infection.

Other

• BRAF mutation and/or primary tumor of microsatellite instability (MSI)
• Pregnant or breast-feeding patients
• Any reason why in the opinion of the investigator, the patient should not participate.

• Willing and able to provide written informed consent.
• Male or female, aged 18-70 years old inclusive at study entry.
• ECOG (Eastern Cooperative Oncology Group) 0 or 1.
• Histologically-proven primary colorectal tumor.
• Bilateral, limited at liver and non-resectable CRLM by consensus in Multidisciplinary Committee.
• Resection of primary colorectal tumor according oncological principles and adequate TNM stage.
• Time from primary colorectal tumor resection to transplant ≥ 12 months.
• Primary colorectal tumor stage ≤ T3N1. If time between primary tumor resection is ≥ 2 years, stage T4N0 or T4N2 is accepted.
• No signs of extrahepatic metastatic disease according to PET/CT scan, CT and pelvic MRI.
• The patient has undergone systemic chemotherapy for a minimum of 3 months at the time of screening and maximum of 2 lines of fluoropyrimidine based chemotherapy combined or not with irinotecan or oxaliplatin associated or no not with targeted therapy based in molecular biomarkers.
• Demonstrated stability or partial regression of CRLM following RECIST criteria v 1.1., at minimum 3 months since the last treatment received and immediately prior to screening.
• CEA (Carcinoembryonic antigen) values ≤ 80 µg/L immediately prior to screening.
• Adequate blood test regarding:
  • Creatinine ≤1.25 x upper normal level or estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73m2 using following the Chronic Kidney disease epidemiology collaboration (CKD-EPI) formula.
  • Platelets ≥80 × 109/L
  • Neutrophiles ≥ 2.5 × 109/L
• Patients with hepatic failure after resection will be considered if it occurs as a consequence of an inadequate preoperative estimation of the functional volume that would have contraindicated the surgery. They should meet the inclusion criteria and none of the exclusion criteria.