Overview

Immunotherapy Using Precision T Cells Specific to Personalized Neo-antigen for the Treatment of Advanced Malignant Tumor of Biliary Tract

Status:
Unknown status
Trial end date:
2017-09-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Second Military Medical University
Treatments:
Gemcitabine
Criteria
Inclusion Criteria:

- 1. Age 18~65 years old, male or female;2. Life expectancy > 6 months;3. Eastern
Cooperative Oncology Group (ECOG) score: 0-2;4. Laboratory examination: ① white blood
cell ≥ 3 x 109/L. blood platelet count ≥ 60 x 109/L; hemoglobin ≥85g/L; ② total
bilirubin ≤100 mol/L; aminopherase less than five times of the normal; ③ serum
creatinine less than 1.5 times of the normal;5. Signed informed consent;6. Patients
with fertility are willing to use contraceptive method.

Exclusion Criteria:

- 1. Expected Overall survival < 6 months;2.Other serious diseases:the heart,lung,
kidney, digestive, nervous, mental disorders, immune regulatory diseases, metabolic
diseases, infectious diseases, Etc.3.serum creatinine > 2.5mg/dL; Serum Glutamic
Oxaloacetic Transaminase (SGOT) > 5 times of the normal;total bilirubin > 100μmol/L;
4.Other drugs, biological, chemotherapy or radiation therapy were used within 1
months;5. Without signed Informed consent.