LDLT in Non Resectable Colo-rectal Cancer Liver Metastasis

NCT05186116 | Recruiting

• 1 other identifier: 470/2021/SPER/AOUMO
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This study is an interventional open label prospective study that aims to assess both overall and disease-free survival of patients treated with LDLT, partial or whole graft LT from deceased donors for unresectable CRLM. Secondary outcomes are graft survival and donor outcomes in terms of safety and quality of life. Donor selection is performed according to the currently used Institutional and National standards and protocols.

Conditions

Colon Adenocarcinoma; Liver Metastasis Colon Cancer

Keywords

LDLT; living donor; CRLM; transplant oncology

Outcome Measures

Primary Outcomes (2)

• Overall survival

  Overall survival of patients treated with LDLT for unresectable CRLM compared to our historical cohort of potentially transplantable patients that underwent chemotherapy only

  5 years

• Disease free survival

  Disease-free survival of patients treated with LDLT for unresectable CRLM compared to our historical cohort of potentially transplantable patients that underwent chemotherapy only

  5 years

Secondary Outcomes (2)

• Graft survival

  5 years

• Donor quality of life

  5 years

Study Arms (1)

LDLT, partial graft, whole graft recipients

EXPERIMENTAL

Patients that undergo LDLT, partial graft or whole graft transplantation for CRLM in the study period

Procedure: Living donor liver transplant, Split liver transplant, RAPID, DDLT

Interventions

Living donor liver transplant, Split liver transplant, RAPID, DDLT PROCEDURE

Transplantation of part of the liver from a living donor, or entire cadaveric graft

LDLT, partial graft, whole graft recipients

Eligibility Criteria

• Age: 18 Years - 77 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria di Modena: lead

Study Sites (1)

Azienda Ospedaliero Universitaria di Modena

Modena, MO, 41124, Italy

RECRUITING

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MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

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: Professor

Study Record Dates

• First Submitted: November 24, 2021
• First Posted: January 11, 2022
• Study Start: January 1, 2022
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2032
• Last Updated: September 25, 2025

Record last verified: 2025-09

Locations

IT (1)