Living Donor Liver Transplantation for Unresectable Colorectal Cancer Liver Metastases

Program Status

Recruiting

Phase

Not Applicable

Prior Immunotherapy Allowed

No

CRC-directed Trial

Yes

Tags

MSI-H/ MMRd, MSS/ MMRp
Location Location Status
Canada
Toronto General Hospital
Toronto, Ontario M5G 2N2
Recruiting

Contacts

Erin Winter, BSc
Contact
416-340-4800 erin.winter@uhn.ca

Inclusion 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

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

NCT ID

NCT02864485

Date Trial Added

2016-08-12

Updated Date

2024-06-18