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

• Status: Recruiting
• Trial end date: 2024-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
• Collaborators: Gruppo Oncologico del Nord-Ovest; Istituto Di Ricerche Farmacologiche Mario Negri
• Treatments: Liver Extracts

Criteria

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