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Living Donor Liver Transplantation for Unresectable Colorectal Cancer Liver Metastases

Colorectal Cancer | Liver Metastases

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.

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Participation Requirements

  • Sex:

    ALL

  • Eligible Ages:

    18 to 68

Participation Criteria

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 Location

Toronto General Hospital
Toronto General Hospital
Toronto, Ontario
Canada

Contact Study Team

Primary Contact

Erin Winter

[email protected]
416-340-4800
Study Sponsored By
University Health Network, Toronto
Participants Required
More Information
Study ID: NCT02864485