Liver MetastasesPhase 2COLTNCT03803436
Improving Outcome of Selected Patients With Non-resectable Hepatic Metastases From Colo-rectal Cancer With Liver Transplantation
A Phase 2 study testing Liver transplant and Chemotherapy in people with Liver Metastases and Colorectal Cancer Metastatic, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 12 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Liver Metastases, Colorectal Cancer Metastatic, Liver Neoplasm
- What is being tested?
- Liver transplant and Chemotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 12 sitesItaly
- Study dates
- 2 Jan 2019to 31 Oct 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Italy12 sites
SOD Clinica di Chirurgia Epatobiliare, Pancreatica e dei Trapianti e SC di Oncologia Medica, Ospedali Riuniti di Ancona
Ancona
ASST Papa Giovanni XXIII
Bergamo, 24127
Chirurgia EBP e dei Trapianti di Fegato e SC di Oncologia Medica, Ospedale Policlinico San Martino
Genova
Fondazione IRCCS Istituto NAzionale Tumori di Milano
Milan, 20133
Ospedale Maggiore di Milano Policlinico
Milan, 20122
Azienda Ospedaliera Ospedale Niguarda Ca' Granda
Milan, 20162
Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione (ISMETT)
Palermo, 90133
GONO Group (Gruppo Oncologico Nord Ovest) TRIPLETE Trial Coordination
Pisa
Fondazione Policlinico Universitario A.Gemelli IRCCS
Roma
Ospedale Universitario Molinette S. Giovanni Battista di Torino
Torino, 10126
Centro Trapianti di Fegato e SC di Oncologia Medica, A.S.U. Integrata di Udine
Udine
Centro Trapianti di Fegato e SC di Oncologia Medica, A.O.U. Integrata di Verona
Verona
About this study
Official title: 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
- Being tested
- Liver transplant, Chemotherapy
- Keywords
- Liver Transplant, Colorectal Cancer, Chemotherapy, Metastasis
- Medical subject headings
- Liver Neoplasms, Neoplasms, Colorectal Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver transplantProcedure or surgery
Liver transplant from cadaveric donors
ChemotherapyDrug
mFOLFOX
ChemotherapyDrug
Panitumumab
| Study group | Role | What they receive |
|---|---|---|
| Study arm | Experimental | Liver transplant Receives: Procedure: Liver transplant |
| Parallel arm | Active comparator | Chemotherapy Receives: Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Time from enrolement to either death or censoring
Measured: 5 years
Secondary outcomes (2)
Progression Free Survival
Time from enrolement to either progression or censoring
Measured: 5 years
Complications rate
Complications according to Dindo Clavien Classification
Measured: 90 days after liver transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2019
- Study start2 Jan 2019
- Primary completion31 Oct 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver MetastasesStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study will compare survival in the population of patients enrolled in the COLT trial with the OS in the COLT-eligible population enrolled in the parallel TRIPLETE trial conducted by the GONO Group.
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Istituto Di Ricerche Farmacologiche Mario Negri, Gruppo Oncologico del Nord-Ovest
- Responsible party
- Sponsor
- Investigators
- Vincenzo Mazzaferro, MD, PhD, Principal investigator, Fondazione IRCCS Istituto Nazionale Tumori di Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03803436
- Sponsor's protocol ID
- INT 108/18
- Acronym
- COLT
- Status last verified
- Oct 2026
- First submitted
- 7 Jan 2019
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sposito C, Pietrantonio F, Maspero M, Di Benedetto F, Vivarelli M, Tisone G, De Carlis L, Romagnoli R, Gruttadauria S, Colledan M, Agnes S, Ettorre G, Baccarani U, Torzilli G, Di Sandro S, Pinelli D, Caccamo L, Sartore Bianchi A, Spreafico C, Torri V, Mazzaferro V. Improving Outcome of Selected Patients With Non-Resectable Hepatic Metastases From Colorectal Cancer With Liver Transplantation: A Prospective Parallel Trial (COLT trial). Clin Colorectal Cancer. 2023 Jun;22(2):250-255. doi: 10.1016/j.clcc.2023.01.003. Epub 2023 Feb 3.
PubMed 36822922
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Outcome of Selected Patients With Non-resectable Hepatic Metastases From Colo-rectal Cancer With Liver Transplantation: a Prospective Parallel Trial
- ClinicalTrials.gov ID
- NCT03803436
- Acronym / sponsor ID
- COLT / INT 108/18
- Keywords
- Liver Transplant, Colorectal Cancer, Chemotherapy, Metastasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoUniversity, hospital or other
- Collaborators
- Istituto Di Ricerche Farmacologiche Mario Negri, Gruppo Oncologico del Nord-Ovest
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 14 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will compare survival in the population of patients enrolled in the COLT trial with the OS in the COLT-eligible population enrolled in the parallel TRIPLETE trial conducted by the GONO Group.
| Arm | Type | Receives |
|---|---|---|
| Study arm | Experimental | Procedure: Liver transplantLiver transplant |
| Parallel arm | Active comparator | Drug: ChemotherapyChemotherapy |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liver transplantLiver transplant from cadaveric donors | Procedure or surgery | Study arm |
| ChemotherapymFOLFOX | Drug | Parallel arm |
| ChemotherapyPanitumumab | Drug | Parallel arm |
Primary outcome
Overall Survival
Time frame: 5 years
Time from enrolement to either death or censoring
2 secondary outcomes
Progression Free Survival
Time frame: 5 years
Complications rate
Time frame: 90 days after liver transplant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Derived from this study: PubMed 36822922Sposito C, Pietrantonio F, Maspero M, Di Benedetto F, Vivarelli M, Tisone G, De Carlis L, Romagnoli R, Gruttadauria S, Colledan M, Agnes S, Ettorre G, Baccarani U, Torzilli G, Di Sandro S, Pinelli D, Caccamo L, Sartore Bianchi A, Spreafico C, Torri V, Mazzaferro V. Improving Outcome of Selected Patients With Non-Resectable Hepatic Metastases From Colorectal Cancer With Liver Transplantation: A Prospective Parallel Trial (COLT trial). Clin Colorectal Cancer. 2023 Jun;22(2):250-255. doi: 10.1016/j.clcc.2023.01.003. Epub 2023 Feb 3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincenzo Mazzaferro, MD, PhD principal investigator
Fondazione IRCCS Istituto Nazionale Tumori di Milano
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Liver transplant and Chemotherapy in people with Liver Metastases and Colorectal Cancer Metastatic, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 12 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03803436, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.