Program Status
RecruitingPhase
Not ApplicablePrior Immunotherapy Allowed
NoCRC-directed Trial
YesTags
MSI-H/ MMRd, MSS/ MMRpLocation | Location Status |
---|---|
Canada | |
Toronto General Hospital Toronto, Ontario M5G 2N2 |
Recruiting |
Contacts
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