Hepatocellular Carcinoma Clinical Trial
Official title:
Sequential, Related Donor Partial Liver Transplantation Followed by Bone Marrow Transplantation for Fibrolamellar or Non-fibrolamellar Hepatocellular Carcinoma (HCC) Including Fibrolamellar HCC
This trial is a phase II, single arm, open-label, single center study to assess a
reduced-intensity conditioning regimen, bone marrow transplantation and high dose PTCy in
recipients of a partial liver allograft from a Human Leukocyte Antigen (HLA)-matched or
-haploidentical living related donor in patients with HCC.
The primary objective of this trial is to characterize recurrence-free survival at 1 year
following bone marrow transplantation among recipients of prior partial liver transplantation
from the same donor.
The purpose of this study is to characterize the safety and anti-tumor efficacy of sequential
partial liver transplantation followed by bone marrow transplantation from the same living
related donor. This treatment applies to patients whose cancer remains confined to the liver
but is too widespread to be removed by surgery or treated by a liver transplant from a
deceased donor. The purpose of this combined treatment is to reduce the risk of the cancer
coming back after the liver transplant The bone marrow transplant may reduce the risk of
cancer relapse in two ways. First, patients who have combined bone marrow and solid organ
transplants may be able to get off all anti-rejection drugs, which inhibit the immune system
from destroying cancer cells. Second, the donor's bone marrow contains cells of the immune
system, which can attack any cancer cells that remain after the liver transplant.
This trial is a phase II, single arm, open-label, single center pilot study to assess a
reduced-intensity conditioning regimen, bone marrow transplantation and high dose
post-transplantation cyclophosphamide (PTCy) in recipients of a partial liver allograft from
a Human Leukocyte Antigen (HLA)-matched or -haploidentical living related donor in patients
with HCC. The trial includes analyses of tumor characteristics and the number and phenotype
of tumor infiltrating lymphocytes in the explanted tumor. The trial also includes periodic
monitoring of circulating hepatocytes to correlate with tumor response.
The study is expected to take two years to complete accrual of six patients, and the primary
objective of this trial is to characterize recurrence-free survival at 1 year following bone
marrow transplantation among recipients of prior partial liver transplantation from the same
donor. Secondary objectives include documenting percentage of patients who become tolerant of
the transplanted liver, i.e. off immunosuppression for >6 months without biochemical evidence
of liver rejection, and characterizing the relationship between donor chimerism and
transplantation tolerance.
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