The Swedish Study of Liver Transplantation for Non-resectable Colorectal Cancer Metastases

Inclusion Criteria:

• Patients with non-resectable, non-ablatable liver metastases from colorectaladenocarcinoma.

• Male or female 18 years or above.

• Primary tumour removed with an R0 resection, and histologically verifiedadenocarcinoma from colon or rectum

• Liver metastases measurable by MRI or CT according to RECIST version 1.1 Imagingwithin 4 weeks prior to inclusion.

• No signs of extrahepatic metastatic disease or local recurrence according to MRI andCT of thorax/abdomen and whole body Positron-emission tomography (PET)/ computedtomography (CT) scan.

• A colonoscopy performed within the last 12 months in order to exclude multifocalcolorectal cancer (CRC) tumours.

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

• Satisfactory blood tests: Hb ≥ 90 g/L (transfusions are permitted to achievebaseline hemoglobin level), White blood cell Count (WBC) >3,0x109/L, Absoluteneutrophil count (ANC) ≥ 1.5 × 10^9/L, platelet Count (PLT) >75, Bilirubin<2 x uppernormal level, Aspartate aminotransferase (ASAT), Alanine aminotransferase (ALAT)<5 xupper normal level, Calculated Creatinine clearance ≥ 50 mL/min(MDRD).

• Received at least 2 months of chemotherapy with no signs of progressive diseaseaccording to RECIST-criteria at the last evaluation before randomization.

• One year or more from the initial CRC diagnosis to the date of inclusion in thestudy

• Patient accepted for transplantation by a national study board

• Signed and dated written informed consent before the start of specific protocolprocedures.

Exclusion Criteria:

• Evidence of extrahepatic disease by PET-CT or CT-thorax/abdomen.

• Pregnant or breast-feeding patients. Women of childbearing potential must have anegative pregnancy test performed within seven days prior to the start of study.

• Weight loss >10% the last 6 months

• Other malignancies within the last 5 years, except CRC and low risk tumours such asbasaliomas.

• Liver metastases larger than 10 cm.

• Pathological lymphatic nodes in the abdomen. If a patient has pathological lymphaticnodules in the hepatoduodenal ligament, a staging operation with histo-pathologicalexamination from the nodules with no signs of tumour cell involvement has to beperformed before inclusion.

• BRAF (a gene that encodes a protein called b-raf) mutation in primary tumour

• microsatellite instability (MSI-H) in primary tumour

• Previous organ transplantation