Liver Metastasis Colon CancerNCT05185245
Liver Transplantation for Non-Resectable Colorectal Liver Metastasis
A study testing Liver Transplantation in people with Liver Metastasis Colon Cancer and Colorectal Cancer, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
The study aims to evaluate the efficacy of liver transplantation in the context of non-resectable colorectal liver metastasis. The primary endpoint is the overall survival in this group of patients while the secondary endpoint is the disease-free survival. Read more about this study
- Who is it for?
- Ages 18 to 73 years
- Conditions the study is for
- Liver Metastasis Colon Cancer, Colorectal Cancer
- What is being tested?
- Liver Transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2021to 30 Mar 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 73 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary tumor resected according to standard oncological practice, p≤T4a, R0 resection
- Colorectal liver metastasis considered as non-resectable either up-front or after previous hepatic resections
- No local recurrence of primary colon cancer confirmed by Positron Emission Tomography, Computed Tomography and colonoscopy
- No extra-hepatic metastatic disease confirmed by Positron Emission Tomography and Computed Tomography
- Good performance status Eastern Cooperative Oncology Group 0 or 1
- Neutrophils > 1.000
Show all 10Show fewer
- Patients who received at least one line of chemotherapy for at least 3 months with partial response or stable disease according to modified Response Evaluation Criteria in Solid Tumours
- Carcino-Embryonic Antigen < 80 µg/L or reduction of ≥ 50% of highest Carcino-Embryonic Antigen level observed
- Written informed consent
- No other contraindications to liver transplantation
Who cannot join
- Presence of other malignancies
- Local recurrence of primary tumor
- Extra-hepatic metastatic disease
- Patients who did not receive any neoadjuvant or adjuvant therapy
- Palliative resection of primary tumor
- Any other reason, according to the investigators, that could be a contraindication to protocol enrollment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Azienda Ospedaliero - Universitaria di Bologna
Bologna, 40138
Matteo Cescon, M.D., +390512144785, matteo.cescon@unibo.it
About this study
The study aims to evaluate the efficacy of liver transplantation in the context of non-resectable colorectal liver metastasis. The primary endpoint is the overall survival in this group of patients while the secondary endpoint is the disease-free survival.
Patients included in this protocol will be evaluated either for whole or partial liver transplantation from deceased or living donors.
Read more
Type of different transplantations proposed are as follows:
- Whole liver graft or partial liver (split) from a deceased donor
- Partial liver graft retrieved from a deceased donor and orthotopically implanted after having performed a left hepatectomy in the recipient.
- Partial liver graft retrieved from a deceased donor and heterotopically implanted if total hepatectomy can not be performed.
- Partial liver graft retrieved from a living donor and orthotopically implanted after having performed total hepatectomy.
- Partial liver graft retrieved from a living donor and orthotopically implanted after having after having performed a left hepatectomy in the recipient.
- Partial liver graft retrieved from a living donor and heterotopically implanted if total hepatectomy can not be performed.
In cases 2-3-5-6 total hepatectomy of native liver can be secondarily performed after having achieved a proper graft hypertrophy in order to avoid a small for size syndrome
- Conditions
- Liver Metastasis Colon Cancer, Colorectal Cancer
- Being tested
- Liver Transplantation
- Keywords
- liver transplantation, non-resectable colorectal liver metastasis
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver TransplantationProcedure or surgery
Liver Transplantation for Non-Resectable Colorectal Liver Metastasis
| Study group | Role | What they receive |
|---|---|---|
| Liver Transplantation | Experimental | Not described Receives: Procedure: Liver Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: 5 years
Secondary outcomes (1)
Disease-Free Survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start1 Apr 2021
- Primary completion30 Mar 2025 (estimated)
- Study completion30 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Metastasis Colon CancerStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05185245
- Sponsor's protocol ID
- LITORALE2020
- Status last verified
- Apr 2021
- First submitted
- 10 Dec 2021
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liver Transplantation for Non-Resectable Colorectal Liver Metastasis
- ClinicalTrials.gov ID
- NCT05185245
- Acronym / sponsor ID
- LITORALE2020
- Conditions
- Liver Metastasis Colon Cancer, Colorectal Cancer
- Keywords
- liver transplantation, non-resectable colorectal liver metastasis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 30 Mar 2030 (estimated)
- First posted
- 11 Jan 2022 (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 study aims to evaluate the efficacy of liver transplantation in the context of non-resectable colorectal liver metastasis. The primary endpoint is the overall survival in this group of patients while the secondary endpoint is the disease-free survival.
Patients included in this protocol will be evaluated either for whole or partial liver transplantation from deceased or living donors.
Type of different transplantations proposed are as follows:
- Whole liver graft or partial liver (split) from a deceased donor
- Partial liver graft retrieved from a deceased donor and orthotopically implanted after having performed a left hepatectomy in the recipient.
- Partial liver graft retrieved from a deceased donor and heterotopically implanted if total hepatectomy can not be performed.
- Partial liver graft retrieved from a living donor and orthotopically implanted after having performed total hepatectomy.
- Partial liver graft retrieved from a living donor and orthotopically implanted after having after having performed a left hepatectomy in the recipient.
- Partial liver graft retrieved from a living donor and heterotopically implanted if total hepatectomy can not be performed.
In cases 2-3-5-6 total hepatectomy of native liver can be secondarily performed after having achieved a proper graft hypertrophy in order to avoid a small for size syndrome
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liver Transplantation | Experimental | Procedure: Liver Transplantation |
Who may qualify
- Ages
- 18 to 73 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Primary tumor resected according to standard oncological practice, p≤T4a, R0 resection
- Colorectal liver metastasis considered as non-resectable either up-front or after previous hepatic resections
- No local recurrence of primary colon cancer confirmed by Positron Emission Tomography, Computed Tomography and colonoscopy
- No extra-hepatic metastatic disease confirmed by Positron Emission Tomography and Computed Tomography
- Good performance status Eastern Cooperative Oncology Group 0 or 1
Key exclusion criteria (6 listed)
- Presence of other malignancies
- Local recurrence of primary tumor
- Extra-hepatic metastatic disease
- Patients who did not receive any neoadjuvant or adjuvant therapy
- Palliative resection of primary tumor
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 TransplantationLiver Transplantation for Non-Resectable Colorectal Liver Metastasis | Procedure or surgery | Liver Transplantation |
Primary outcome
Overall Survival
Time frame: 5 years
1 secondary outcome
Disease-Free Survival
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
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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.
IRCCS Azienda Ospedaliero - Universitaria di Bologna
Bologna, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liver Transplantation in people with Liver Metastasis Colon Cancer and Colorectal Cancer, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site 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 10 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: looking for participants now, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. 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?
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 11 Jan 2022.