Recruiting

LDLT

Sponsor:

University Health Network, Toronto

Code:

NCT02864485

Conditions

Colorectal Cancer

Liver Metastases

Eligibility Criteria

Sex: All

Age: 18 - 68

Healthy Volunteers: Not accepted

Interventions

live donor liver transplantation

Study Details

Brief summary:

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.

Conditions

Colorectal Cancer

Liver Metastases

Study ID

NCT02864485

Start date

Aug 3, 2016

Status verified date

Jun, 2024

Completion date

Dec, 2030

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 68

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Previous or concurrent cancer (with some exceptions)
  • prior lung resection
  • Progression of LM at any timepoint prior to transplant surgery
  • Renal dysfunction with an estimated creatinine clearance of less than 50 ml/min
  • Pulmonary insufficiency
  • History of cardiac disease
  • Known history of human immunodeficiency virus (HIV) infection or chronic hepatitis B and/or C infection.
  • Patients with debilitating neuropathy. (CTCAE > grade 2)
  • BRAF + tumors
  • Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: transplantation

Live donor liver transplantation for the treatment of unresectable colorectal cancer liver metastases

Interventions

live donor liver transplantation

live donor liver transplantation

Primary outcome measure

  • patient survival [ Time Frame: 5 years ]
  • disease-free survival [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Erin Winter, BSc

416-340-4800erin.winter@uhn.ca

Locations

Toronto General Hospital

Recruiting

Toronto, Ontario, Canada, M5G 2N2

Contacts

Erin Winter

416-340-4800erin.winter@uhn.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Jun 18, 2024

Last verified

Jun, 2024

Keywords

  • Live donor liver transplantation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2024-06-18.