Objectives: The purpose of this study is to evaluate the safety and efficacy of dendritic cell-precision multiple antigen T cells with transcatheter arterial chemoembolization in the treatment of hepatocellular carcinoma. Methods: This study designs a novel therapy using dendritic cell-precision multiple antigen T cells. 60 patients will be enrolled. They are randomly divided into transcatheter arterial chemoembolization group and dendritic cell-precision multiple antigen T cells combined with transcatheter arterial chemoembolization group. Treatments will be performed every 3 weeks with a total of three periods. The mail clinical indicators are Progression-Free-Survival and Overall Survival.
A total of 60 patients may be enrolled over a period of 1-2 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
lipiodol 10-20ml,MMC 8~10mg,EADM20~40mg. According to tumor area of maximum diameter,0.1~0.2ml/cm2 hepatic arterial infusion.Each cycle received one TACE treatment on day 13,34,55.
DC suspension (1×107 DC+ physiological saline + 0.25% human serum albumin) 1ml for each infusion, subcutaneous injection for each infusion 3 cycles, each cycle received two infusions on day 19, 20; 40, 41; 61, 62.
lipiodol 10-20ml,hepatic arterial infusion
MMC 8~10mg. According to tumor area of maximum diameter,0.1~0.2ml/cm※2, hepatic arterial infusion.
EADM20~40mg. According to tumor area of maximum diameter,0.1~0.2ml/cm※2 hepatic arterial infusion.
PMAT cell suspension (1-6×109 PMAT + physiological saline + 0.25% human serum albumin) 300ml for each infusion, IV (in the vein) for each infusion 3 cycles, each cycle received one infusions on day 21, 42, 63.
Eastern Hepatobiliary Surgery Hospital
Shanghai, China
RECRUITINGOverall survival
Time frame: 2 years
Progress-free survival
Time frame: 2 years
Quality of life
Quality of life core questionnaire will be used.
Time frame: 2 years
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