Safety and Efficacy of γδ T Cell Against Gastric Cancer

Beijing Doing Biomedical

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Gastric Cancer

Treatments: Biological: CIK; Biological: γδ T; Biological: CIK and γδ T

Study type: Interventional

Funder types: Industry

Identifiers

NCT02585908

Doing-001

Details and patient eligibility

About

In this study, safety and effects of γδT cells on human gastric cancer are going to be investigated.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 4 patient groups

Experimental Group A(control group)

No Intervention group

Description:

regular treatment and follow up

Experimental Group B

Experimental group

Description:

CIK will be used against tumor cells.

Treatment:

Biological: CIK

Experimental Group C

Experimental group

Description:

γδ T will be used against tumor cells.

Treatment:

Biological: γδ T

Experimental Group D

Experimental group

Description:

CIK and γδ T will be used against tumor cells.

Treatment:

Biological: CIK and γδ T