Liver Transplantation for Non-Resectable Colorectal Liver Metastases Without Local Treatment Options

NCT07811453 | Not Yet Recruiting DMC

• 2 other identifiers: 2002875670117408
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

Patients whose colorectal cancer has spread to the liver, and whose liver metastases cannot be removed by surgery or destroyed by ablation, currently receive palliative chemotherapy in Germany. Fewer than one in ten of these patients survive five years. International studies have shown that replacing the whole liver by transplantation can achieve much longer survival in carefully selected patients, because removing the entire liver removes all of the tumour when the disease is confined to it. The TransMet trial reported five-year survival of 57% with transplantation plus chemotherapy, compared with 13% for chemotherapy alone. This approach is not yet available in German routine care, where liver transplantation for this indication is permitted only within a clinical study. GTO-001 will enrol approximately 260 adults aged 18 to 65 years with colorectal liver metastases that are confined to the liver, that cannot be removed or ablated, and that have remained stable or improved for at least six months on chemotherapy. Every participant is assessed by a newly established National Tumor Board for Transplant Oncology, which meets monthly, reviews the imaging and case independently of the local centre, and decides whether the patient may be listed for transplantation. Patients who are approved are listed with a study-specific priority status, continue their chemotherapy while they wait, and undergo a surgical inspection of the abdomen at the start of the transplant operation to confirm that the cancer has not spread outside the liver. Participants who are not listed, or in whom transplantation is not performed, remain in the study and are followed in the same way. The main question is how many patients are alive five years after transplantation. The study also measures how many of the patients assessed are eventually listed and transplanted, how many leave the waiting list because their disease progresses or becomes operable, survival after each of the treatments patients actually receive, how well the transplanted livers function, and complications after surgery. Because the study follows everyone who is assessed, it will also establish for the first time how many patients in Germany genuinely qualify for this treatment. Participants are followed for five years after transplantation; the study runs until 2036.

Conditions

Colorectal Neoplasms; Liver Neoplasms; Neoplasm Metastases; Colorectal Liver Metastases; Metastatic Colorectal Cancer (CRC)

Keywords

liver transplantation; transplant oncology; colorectal liver metastases; unresectable; metabolic tumor volume; PET/CT; organ allocation; Eurotransplant; central tumour board; circulating tumour DNA

Outcome Measures

Primary Outcomes (1)

• Overall survival at 5 years after liver transplantation

  Proportion of transplanted participants alive 5 years after liver transplantation, estimated by the Kaplan-Meier method with a two-sided 95% confidence interval, in the transplant cohort (participants transplanted after approval by the National Tumor Board and without study-specific contraindications at the time of transplantation). Time origin is the date of transplantation; the event is death from any cause; participants with missing survival information from a given visit onwards are censored at the last completed follow-up visit. Higher values indicate better outcome. The study is designed to demonstrate 5-year survival above 50%, equivalent to median survival exceeding 5 years.

  60 months after liver transplantation

Secondary Outcomes (11)

• Proportion of enrolled participants listed for liver transplantation

  From enrolment to end of recruitment (36 months)

• Proportion of listed participants who undergo liver transplantation

  From listing to end of study (up to 108 months)

• Waiting-list dropout after listing

  From listing to end of study (up to 108 months)

• Overall survival from enrolment

  12, 36 and 60 months after enrolment

• Progression-free survival from enrolment

  12, 36 and 60 months after enrolment

Other Outcomes (3)

• Association of the Oslo score with 5-year survival after liver transplantation

  60 months after liver transplantation

• Association of the Fong Clinical Risk Score with 5-year survival after liver transplantation

  60 months after liver transplantation

• Association of circulating tumour DNA with 5-year survival after liver transplantation

  60 months after liver transplantation

Study Arms (1)

Liver transplantation pathway

EXPERIMENTAL

Participants with liver-confined, non-resectable colorectal liver metastases stable for at least six months on active chemotherapy are assessed centrally by the National Tumor Board for Transplant Oncology. Those approved are listed for liver transplantation with a study-specific ReMELD-Na Standard Exception, continue systemic chemotherapy until transplantation, undergo mandatory staging exploration, and receive liver transplantation. Participants not approved or not transplanted remain enrolled and are followed identically.

Procedure: Liver transplantation

Interventions

Liver transplantation PROCEDURE

Orthotopic liver transplantation with a full or split graft from a deceased donor allocated by Eurotransplant under a study-specific ReMELD-Na Standard Exception, or from a living donor where evaluated as suitable by the participating centre. Staged hepatectomy techniques are not permitted. Machine perfusion may be used for graft assessment and preservation in accordance with the German guidelines for organ transplantation. Systemic chemotherapy continues until transplantation, excluding anti-EGFR antibodies, anti-VEGF antibodies and checkpoint inhibitors. Immunosuppression and perioperative care follow local site protocols; post-transplant chemotherapy is resumed at the discretion of the local tumour board and is not a study-specific intervention. Re-transplantation may be requested from Eurotransplant for primary non-function or surgical complications where the recipient meets the criteria of the German guidelines.

Liver transplantation pathway

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• LMU Klinikum: collaborator
• German Cancer Aid: collaborator
• University Hospital Muenster: collaborator

Study Sites (1)

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

Berlin, State of Berlin, 13353, Germany

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Liver Neoplasms; Neoplasm Metastasis

Interventions

Liver Transplantation

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Liver Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Digestive System Surgical Procedures; Surgical Procedures, Operative; Organ Transplantation; Transplantation

Central Study Contacts

Nathanael Raschzok, Prof. Dr.

CONTACT

+49 30 450 552 001; nathanael.raschzok@charite.de

Simon Moosburner, Priv.-Doz. Dr.

CONTACT

simon.moosburner@charite.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Overall Study lead

Study Record Dates

• First Submitted: September 3, 2026
• First Posted: September 10, 2026
• Study Start (Estimated): April 1, 2027
• Primary Completion (Estimated): March 31, 2036
• Study Completion (Estimated): March 31, 2036
• Last Updated: September 10, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)