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Living liver donors offer new hope for advanced colon cancer patients

NCT ID NCT05186116

Disease control Sponsor: Azienda Ospedaliero-Universitaria di Modena Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a liver transplant from a living donor can help people with colon cancer that has spread only to the liver and cannot be removed by surgery. About 25 adults will receive a partial liver from a healthy donor. The goal is to see if this approach helps them live longer and stay cancer-free compared to standard chemotherapy alone. Donors will also be monitored for safety and quality of life.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 25 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2022

Expected to finish

Jan 2032

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 77 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥18. * Histologically confirmed colon and rectum (intraperitoneal) adenocarcinoma. * Pathological classification of primary tumor as pT1-3, without peritoneal tumor deposits, absence of mucinous component \>50%, confirmed R0 resection, no limitations for RAS mutations, B-RAF wild type. * No signs of extra hepatic metastatic disease or local recurrence according to CT scan+MRI+PET/CT scans. * 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 (complete \[CR\] or partial response \[PR\] or standard disease \[SD\]) during second- line treatment for at least 4 months. * Carcinoembryonic Antigen (CEA) values stable or decreasing during the enrollment prior to liver transplant. * Performance status, ECOG (Eastern Cooperative Oncology Group) 0-2. * Signed informed consent and expected cooperation of the patients for the treatment and follow-up, and national/local regulations. Exclusion Criteria: * Hereditary CRC syndromes including FAP (Familial adenomatous polyposis) and Lynch syndrome. * Prior extra hepatic metastatic disease or primary tumor local relapse. * Palliative resection of primary CRC tumor. * Disease progression * Other malignancies in the previous 5 years (with exception of in situ cervical carcinoma and basal cell carcinoma; superficial bladder tumors are allowed if curatively treated). * Active intra-venous or alcohol abusers (patients may be eligible if abstention \> 6 months is demonstrated) * Active HIV infection * Psychiatric disorders and patient low compliance * Any reason why, in the judgment of the investigators, the patient should not participate (to be formally declared)

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Conditions

The condition(s) this trial relates to.

colon adenocarcinoma colonic neoplasm metastasis from malignant tumor of colon

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colon adenocarcinoma Liver metastasis colon cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Azienda Ospedaliero Universitaria di Modena

    RECRUITING

    Modena, MO, 41124, Italy

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