Improving Outcome of Selected Patients With Non-resectable Hepatic Metastases From Colo-rectal Cancer With Liver Transplantation

Improving Outcome of Selected Patients With Non-resectable Hepatic Metastases From Colo-rectal Cancer With Liver Transplantation: a Prospective Parallel Trial

The COLT trial is an investigator-driven, multicenter, non-randomized, open-label, controlled, prospective, parallel trial, aimed at assessing the efficacy (in terms of overall survival: OS) of liver transplantation (LT) in liver-only CRC metastases, compared with a matched cohort of patients bearing the same tumor characteristics, collected during the same time period and included in a phase III Italian RCT on triplet chemotherapy+antiEGFR

Inclusion Criteria:

• Histologically confirmed non-mucinous colon adenocarcinoma.
• Primary tumor as pT1-3, pN0 or pN1 (metastases in < 4 regional lymph nodes), confirmed R0 resection.
• RAS and BRAF wild-type & MSS molecular status as per local testing.
• Liver metastases not eligible for curative liver resection
• Objective response according to RECIST 1.1 to first-line treatment, with sustained response for at least 4 months, OR disease control (CR+PR+SD) during second-line treatment for at least 4 months.
• A maximum of two prior chemotherapy treatment lines.
• Performance status, ECOG 0.
• Satisfactory blood tests Hb >10g/dl, neutrophils >1.0 (after any G-CSF), TRC >75, Bilirubin<2 x upper normal level, AST, ALT<5 x upper normal level, creatinine <1.25 x upper normal level.
• CEA<50 ng/ml

Exclusion Criteria:

• Hereditary CRC syndromes including FAP and Lynch syndrome.
• Prior extra hepatic metastatic disease or primary tumor local relapse.
• Extra-peritoneal cancers (rectum).
• Other malignancies in the previous 5 years
• Active intra-venous or alcohol abusers
• HIV infection