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.
| Status | Recruiting |
| Enrollment | 40 |
| Est. completion date | September 2017 |
| Est. primary completion date | March 2017 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
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: ? white blood cell = 3 x 109/L. blood platelet count = 60 x 109/L; hemoglobin =85g/L; ? total bilirubin =100 mol/L; aminopherase less than five times of the normal; ? 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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| China | Eastern Hepatobiliary Surgery Hospital | Shanghai |
| Lead Sponsor | Collaborator |
|---|---|
| Second Military Medical University |
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* Note: There are 43 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall survival | 2 yeas | No | |
| Secondary | Progress-free survival | 2 yeas | No | |
| Secondary | Quality of life | Quality of life core questionnaire will be used. | 2 yeas | No |