Safety and Efficacy of γδ T Cell Against Gastric Cancer

NCT ID: NCT02585908

Last Updated: 2019-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-31

Study Completion Date

2022-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Gastric Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Experimental Group A(control group)

regular treatment and follow up

Group Type NO_INTERVENTION

No interventions assigned to this group

Experimental Group B

CIK will be used against tumor cells.

Group Type EXPERIMENTAL

CIK

Intervention Type BIOLOGICAL

CIK cells will be used against tumor cells.

Experimental Group C

γδ T will be used against tumor cells.

Group Type EXPERIMENTAL

γδ T

Intervention Type BIOLOGICAL

γδ T cells will be used against tumor cells.

Experimental Group D

CIK and γδ T will be used against tumor cells.

Group Type EXPERIMENTAL

CIK and γδ T

Intervention Type BIOLOGICAL

CIK and γδ T cells will be used against tumor cells.

Interventions

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CIK

CIK cells will be used against tumor cells.

Intervention Type BIOLOGICAL

γδ T

γδ T cells will be used against tumor cells.

Intervention Type BIOLOGICAL

CIK and γδ T

CIK and γδ T cells will be used against tumor cells.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Doing Biomedical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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li gangyi, master

Role: STUDY_CHAIR

Beijing Doing Biomedical Co., Ltd.

Locations

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The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status

First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, China

Site Status

Huai'An First People'S Hospital

Huaian, Jiangsu, China

Site Status

Hangzhou Cancer Hospital

Hangzhou, Zhejiang, China

Site Status

Countries

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China

Central Contacts

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xie yanyun, master

Role: CONTACT

086-15601041145

li gangyi, master

Role: CONTACT

086-13901106501

Other Identifiers

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Doing-001

Identifier Type: -

Identifier Source: org_study_id

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