Hepatocellular Carcinoma Clinical Trial
Official title:
Safety Study of Nature Killer Cells From Sibship to Treat the Recurrence of Hepatocellular Carcinoma After Liver Transplantation
The purpose of this study is to explore the safety of NK cells from Sibship in patients with recurrent hepatocellular carcinoma after liver transplantation.
Hepatocellular carcinoma (HCC) is one of the indications for the liver transplantation. With
the advancement of liver transplantation associated science and technology, the recurrence
of tumor posttransplantation has become the principal contradiction to worsen the prognosis
and therefore the prevention of recurrence of HCC is the key to improve the efficacy of
liver transplantation. Adoptive cellular immunotherapy has been applied in various malignant
tumors including HCC and has obtained significant effects. But for patients with liver
transplant in immunosuppressed states, to successfully apply the immune cells to prevent and
treat HCC relapse after liver transplantation must balance immunosuppression and anti-tumor
immunity. It is necessary to consider the safety of adoptive cellular immunotherapy,and it
is also necessary to consider the effectiveness of treatment that the immune cells in the
immunosuppression state can exert anti-tumor effects. Natural killer cells (NK cells) have
MHC-unrestricted killing effect on malignant tumor cells and are not major mediating cells
for GVHD, and might be an optimum choice to meet the above requirements.
Patients with confirmed recurrence of hepatocellular carcinoma after liver transplantation
at the Third Affiliated Hospital of Sun Yat-sen University were enrolled.Participants in the
study will be assigned to one of three treatment arms:
Arm A: Participants will received conventional treatment and low dose of NK cells treatment
for 4 times. Arm B: Participants will received conventional treatment and normal dose of NK
cells treatment for 4 times. Arm C: Participants will received conventional treatment and
normal dose of NK cells treatment for 8 times. The cultured NK cells from the peripheral
blood of the same blood type were taken and infused at intervals of two weeks. Periodic
liver function recheck and imaging examination were conducted for 6 months after the last NK
cells infusion.
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Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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