NCT02864485Active, not recruiting

Living Donor Liver Transplantation for Unresectable Colorectal Cancer Liver Metastases

Assessment of a Protocol Using a Combination of Neo-adjuvant Chemotherapy Plus Living Donor Liver Transplantation for Non-Resectable Liver Metastases From Colorectal Cancer

Source: ClinicalTrials.gov · Last updated 2 Oct 2026

Brief summary (registry, in English)

Patients with unresectable liver metastases (LM) from colorectal cancer (CRC)have a poor prognosis. In patients with resectable disease, surgery offers a distinct survival benefit. This study will offer live donor liver transplantation (LDLT) to select patients with unresectable metastases that are 1) limited to the liver and 2) stable (non-progressing) on standard chemotherapy. Potential participants will be evaluated for liver transplant suitability and must also have a willing, healthy living donor come forward for evaluation. Those participants who undergo LDLT will be followed for survival, disease-free survival and quality of life for 5 years and compared to a "control group" of participants who drop out of study prior to transplantation due to reasons other than cancer progression.

Status (registry): Active, not recruiting
Study type: Interventional
Enrollment: 20 (estimated)
First submitted: 4 Aug 2016
Start date: 3 Aug 2016
Primary completion date: 30 Nov 2026
Lead sponsor: University Health Network, Toronto
Diseases: Colorectal cancer
NCT number: NCT02864485

What you commit to

Study type: Interventional
Planned participants: 20
From 3 Aug 2016 to the primary completion date, 30 Nov 2026
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Previous or concurrent cancer (with some exceptions)
prior lung resection
Progression of LM at any timepoint prior to transplant surgery

Other illness

Pulmonary insufficiency
History of cardiac disease
Known history of human immunodeficiency virus (HIV) infection or chronic hepatitis B and/or C infection.
Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study

Lab values

Renal dysfunction with an estimated creatinine clearance of less than 50 ml/min

Other

Patients with debilitating neuropathy. (CTCAE \> grade 2)
BRAF + tumors

Who the study is looking for

Must reside in Canada
ECOG ( Eastern Cooperative Oncology Group) score : 0-1 at all times prior to LDLT (excursions to ECOG 2 allowed at investigator's discretion)
Proven colorectal Liver Metastases (LM).
Willing and able to provide written informed consent.
Negative serum pregnancy test for women of childbearing potential
Both men and women must agree to use adequate barrier birth control measures during the course of the trial.
At least 1 "acceptable", ABO-compatible living donor has stepped forward
Primary Colorectal cancer tumor stage is ≤T4a
Time from primary CRC resection to transplant is ≥6 months
Bilateral and non-resectable LM
No major vascular invasion by LM; metastases isolated to liver
The patient has undergone systemic chemotherapy (eg. FOLFOX +/- bevacizumab or FOLFIRI +/- bevacizumab) for ≥3 months
demonstrated stability or regression of LM over at minimum the 3 months preceding screening
Carcinoembryonic Antigen (CEA) values are stable or decreasing at all timepoints prior to the transplant surgery.

Age in the registry: 18 years to 68 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Toronto General Hospital Coordinator of this site? Confirm its status	Toronto	Canada	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.