Clinical trial NCT02632019: Immunotherapy Using Precision T Cells Specific to Personalized Neo-antigen for the Treatment of Advanced Malignant Tumor of Biliary Tract
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Advanced Biliary Tract Malignant Tumor
Keywords: advanced biliary tract malignant tumor
dendritic cell
precision T cell for neo-antigen
Lead sponsor: Second Military Medical University
Sponsor class: OTHER
First posted: 2015-12-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: A total of 40 patients may be enrolled over a period of 1-2 years.

Eligibility 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.

Primary outcomes:
measure: Overall survival
timeFrame: 2 yeas
Secondary outcomes:
measure: Progress-free survival
timeFrame: 2 yeas
measure: Quality of life
timeFrame: 2 yeas
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Eastern Hepatobiliary Surgery Hospital
Study officials:
affiliation: Eastern Hepatobiliary Surgery Hospital
name: Xiaoqing Jiang, MD
role: STUDY_CHAIR
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