NCT03803436CompletedPhase 2
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
Source: ClinicalTrials.gov · Last updated 21 Oct 2026
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 38 (actual)
- First submitted
- 7 Jan 2019
- Start date
- 2 Jan 2019
- Primary completion date
- 31 Oct 2025
- Lead sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
- NCT number
- NCT03803436
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 38
- From 2 Jan 2019 to the primary completion date, 31 Oct 2025
- 12 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior extra hepatic metastatic disease or primary tumor local relapse.
- Other malignancies in the previous 5 years
Other illness
- Hereditary CRC syndromes including FAP and Lynch syndrome.
- Extra-peritoneal cancers (rectum).
- HIV infection
Other
- Active intra-venous or alcohol abusers
Who the study is looking for
- 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
Age in the registry: 18 years to 69 years · Sex: All · Does not accept healthy volunteers
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| SOD Clinica di Chirurgia Epatobiliare, Pancreatica e dei Trapianti e SC di Oncologia Medica, Ospedali Riuniti di Ancona Coordinator of this site? Confirm its status | Ancona | Italy | Unknown status |
| Asst Papa Giovanni XXIII Coordinator of this site? Confirm its status | Bergamo | Italy | Unknown status |
| Chirurgia EBP e dei Trapianti di Fegato e SC di Oncologia Medica, Ospedale Policlinico San Martino Coordinator of this site? Confirm its status | Genova | Italy | Unknown status |
| Azienda Ospedaliera Ospedale Niguarda Ca' Granda Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Ospedale Maggiore di Milano Policlinico Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Fondazione IRCCS Istituto Nazionale Tumori di Milano Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione (ISMETT) Coordinator of this site? Confirm its status | Palermo | Italy | Unknown status |
| GONO Group (Gruppo Oncologico Nord Ovest) TRIPLETE Trial Coordination Coordinator of this site? Confirm its status | Pisa | Italy | Unknown status |
| Fondazione Policlinico Universitario A. Gemelli IRCCS Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Ospedale Universitario Molinette S. Giovanni Battista di Torino Coordinator of this site? Confirm its status | Torino | Italy | Unknown status |
| Centro Trapianti di Fegato e SC di Oncologia Medica, A.S.U. Integrata di Udine Coordinator of this site? Confirm its status | Udine | Italy | Unknown status |
| Centro Trapianti di Fegato e SC di Oncologia Medica, A.O.U. Integrata di Verona Coordinator of this site? Confirm its status | Verona | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.