Pancreatic Cancer
Conditions
Keywords
Immunotherapy, γδ T Cell, Pancreatic Cancer
Brief summary
In this study, effects of γδT cells on human Pancreatic Cancer in combination with tumor reducing surgery, for example IRE going to be investigated.
Detailed description
Pancreatic tumor will be removed using tumor reducing surgery such as IRE. PBMC of the healthy donor will be separated from peripheral blood. After making them potential cancer killer γδ T Cell, they will be infused to the patients as an immunotherapy treatment.
Interventions
PROCEDUREIRE surgery
IRE surgery will be used in local tumor
BIOLOGICALIRE plus γδ T cells
Combination IRE surgery and γδ T cell will be used in Pancreatic Cancer
Sponsors
Fuda Cancer Hospital, Guangzhou
Jinan University Guangzhou
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. age: \>18 years 2. participants older than 18 years with either LAPC according to the American Joint Committee on Cancer (AJCC) criteria or isolated local recurrence with a maximum tumor diameter of 5 cm were considered eligible after pathologic confirmation 3. will receive IRE, gd Tcells 4. life expectancy: more than 3 months 5. ability to understand the study protocol and a willingness to sign a written informed consent document 6. adequate liver and renal function were required 7. intolerant or refused to chemotherapy or to chemotherapy
Exclusion criteria
1. patients with other kinds of cancer 2. history of coagulation disorders or anemia 3. heart disease and diabetes 4. history of epilepsy, severe coronary disease, a history of level 3 hypertension，myelosuppression, autoimmune disease 5. a performance status score of \>2
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS | 2 years | PFS was defined as the interval between treatment initiation and local relapse |
| OS | 2 year | OS was calculated as the interval from treatment initiation to death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CA 19-9 | 3 months | The serum concentrations of CA19-9 were evaluated by a chemiluminescent immunoassay before treatment and 90 days after treatment. |
| Tumor size | 3 months | The tumor responses of the enrolled patients were assessed by CT in accordance with RECIST v1.1.Institute Common Terminology Criteria for Adverse Events (v4.0). |
| CTC | 3 months | The absolute number of CD45-CK+ CD326+ cells was used to quantitate the CTC levels. |
Countries
China
Outcome results
None listed