Gastric Cancer
Conditions
Brief summary
In this study, safety and effects of γδT cells on human gastric cancer are going to be investigated.
Detailed description
PBMC of the patient will be separated from peripheral blood. After making them potential cancer killer γδ T Cell and CIK, they will be infused to the patients as immunotherapy.
Interventions
BIOLOGICALCIK
CIK cells will be used against tumor cells.
BIOLOGICALγδ T
γδ T cells will be used against tumor cells.
BIOLOGICALCIK and γδ T
CIK and γδ T cells will be used against tumor cells.
Sponsors
Beijing Doing Biomedical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age:30-75 2. Karnofsky performance status \>50 3. Diagnosis with gastric cancer based on histology or the current accepted radiological measures. 4. Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ 5. Patients who have a life expectancy of at least 12 weeks 6. Ability to understand the study protocol and a willingness to sign a written informed consent document
Exclusion criteria
1. Any significant medical or psychiatric illness that would prevent the patient from giving informed consent or from following the study procedures. 2. Known human immunodeficiency virus (HIV) infection. 3. Active and/or severe infection (e.g. tuberculosis, sepsis and opportunistic infections, active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection). 4. Other serious underlying medical conditions, which, in the Investigator's judgment, could impair the ability of the patient. 5. Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduced size of the tumor. | up to one year | Tumor load will be evaluated by RECIST criteria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety, as measured by the rate of adverse events and serious adverse events | up to two years | Safety, as measured by the rate of adverse events and serious adverse events |
Countries
China
Contacts
Primary Contactxie yanyun, master
Backup Contactli gangyi, master
Outcome results
None listed