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Replacing the whole liver: a radical bid to outlast colorectal cancer

NCT ID NCT07811453

Cure Sponsor: Charite University, Berlin, Germany Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 10, 2026 · Last updated Sep 11, 2026 · Updated 1 time

Summary

This study tests whether liver transplantation can extend survival for adults with colorectal cancer that has spread only to the liver and cannot be removed or destroyed by local treatments. About 260 participants aged 18 to 65 will receive a new liver from a deceased or living donor, while continuing chemotherapy until surgery. A national tumor board reviews each case to decide who can be listed for transplant. Researchers will track how many participants are alive five years after transplantation and monitor liver function and complications.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
liver transplantation
What this could lead to
If it works, liver transplantation could become a standard option for people whose colorectal cancer has spread only to the liver and cannot be removed by surgery. It may offer a chance at long-term survival where chemotherapy alone rarely controls the disease.
What could go wrong
This is a complex operation with serious risks, including organ rejection, infection, and complications from major surgery. The trial is not randomized, so comparing transplant recipients with those who receive chemotherapy alone has limits, and the benefit seen in earlier international studies may not hold in a larger German population.

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 260 people

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

Expected to start

Apr 2027

An estimate. Start dates often move.

Expected to finish

Mar 2036

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 65 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 to 65 years at enrolment * ECOG performance status 0 or 1 * Written informed consent before any study-related procedure * Colorectal liver metastases stable for at least 6 months under active chemotherapy of no more than 2 lines * Colorectal liver metastases not amenable to curative local treatment by resection or ablation because of insufficient liver capacity or future liver remnant, as judged by the local interdisciplinary tumour board * For metachronous colorectal liver metastases: a colorectal primary resected in the past with T4a or lower and local R0 status * For synchronous colorectal liver metastases: a potentially curatively resectable primary * No evidence of peritoneal disease, as documented by a surgical report within the preceding 36 months * Suitability for liver transplantation according to local centre criteria * Participants of childbearing potential: negative highly sensitive pregnancy test before inclusion, and use of a contraceptive method with a failure rate below 1%, or confirmed post-menopausal status Exclusion Criteria: * Inability to give informed consent * General contraindications to liver transplantation * Large-vessel infiltration * Extrahepatic disease, including lymph node involvement * Listing for multi-organ transplantation * Prior solid organ or bone marrow transplantation * BRAF V600E mutation in the molecular pathology of the colorectal primary * MSI-H/dMMR status in the molecular pathology of the colorectal primary * Breastfeeding * Institutionalisation by order of a court or public authority * Dependence on the overall study lead, the investigator or the study site * Participation in another clinical study with an investigational medicinal product or medical device

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal neoplasm liver and intrahepatic bile duct neoplasm Liver Neoplasms metastatic neoplasm Neoplasm Metastasis

As listed by the trial registrant

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

Colorectal liver metastases Colorectal neoplasms Liver neoplasms Metastatic colorectal cancer (CRC) Neoplasm metastases

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

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Charité - Universitätsmedizin Berlin, Department of Surgery, Campus Charité Mitte | Campus Virchow-Klinikum

    Berlin, State of Berlin, 13353, Germany

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