Advanced Biliary Tract Malignant Tumor Clinical Trial
Official title:
A Clinical Study of Adoptive Cellular Immunotherapy Using Precision T Cells Specific to Personalized Neo-antigen in Treating Patients With Advanced Malignant Tumor of Biliary Tract
Objectives:
The purpose of this study is to evaluate the safety and prognosis of dendritic
cell-precision T cell for neo-antigen in the treatment of advanced biliary tract malignant
tumor.
Methods:
This study designs a novel therapy using dendritic cell-precision multiple antigen T cells.
40 patients will be enrolled. They are randomly divided into gemcitabine group and dendritic
cell-precision T cell for neo-antigen combined with gemcitabine group. Gemcitabine
treatments will be performed once a week with a total of six times. Dendritic cell-precision
T cell for neo-antigen combined with gemcitabine treatment: Gemcitabine: once a week with a
total of six times before 60 days prior to the start of drawing blood. Dendritic
cell-precision T cell for neo-antigen: once per 3 weeks with a total of three periods. The
mail clinical indicators are Progression-Free-Survival and Overall Survival.
A total of 40 patients may be enrolled over a period of 1-2 years. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment