Safety and Efficacy of γδ T Cell Against Gastric Cancer | NCT02585908

Studies
Safety and Efficacy of γδ T Cell Against Gastric Cancer

NCT02585908

Sponsor

Beijing Doing Biomedical Co., Ltd.

Status

Unknown status

Last Update Posted

Nov 13, 2019Actual

Enrollment

120Estimated

Phase

Phase 1Phase 2

Conditions

Gastric Cancer

Interventions

CIK
γδ T
CIK and γδ T

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2019Estimated

Primary Completion Date

Dec 2021Estimated

Completion Date

Dec 2022Estimated

First Submitted Date

Oct 22, 2015

First Submission Date that Met QC Criteria

Oct 22, 2015

First Posted Date

Oct 26, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 11, 2019

Last Update Posted Date

Nov 13, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental Group A(control group)	No Intervention	regular treatment and follow up
Experimental Group B	Experimental	CIK will be used against tumor cells.	Biological: CIK
Experimental Group C	Experimental	γδ T will be used against tumor cells.	Biological: γδ T
Experimental Group D	Experimental	CIK and γδ T will be used against tumor cells.	Biological: CIK and γδ T

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CIK	Biological	CIK cells will be used against tumor cells.	Experimental Group B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reduced size of the tumor.	Tumor load will be evaluated by RECIST criteria.	up to one year

Secondary Outcomes

Measure	Description	Time Frame
Safety, as measured by the rate of adverse events and serious adverse events	Safety, as measured by the rate of adverse events and serious adverse events	up to two years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age:30-75
Karnofsky performance status >50
Diagnosis with gastric cancer based on histology or the current accepted radiological measures.
Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ
Patients who have a life expectancy of at least 12 weeks
Ability to understand the study protocol and a willingness to sign a written informed consent document

Exclusion Criteria:

Any significant medical or psychiatric illness that would prevent the patient from giving informed consent or from following the study procedures.
Known human immunodeficiency virus (HIV) infection.
Active and/or severe infection (e.g. tuberculosis, sepsis and opportunistic infections, active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection).
Other serious underlying medical conditions, which, in the Investigator's judgment, could impair the ability of the patient.
Pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
xie yanyun, master	Contact	086-15601041145		yanyun_xie@doingtimes.com
li gangyi, master	Contact	086-13901106501		gangyi_li@doingtimes.com

Overall Officials

Name	Affiliation	Role
li gangyi, master	Beijing Doing Biomedical Co., Ltd.	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The First Affiliated Hospital of Guangzhou Medical University		Guangzhou	Guangdong	510120	China

Condition Browse Module

MeSH Terms

ID	Term
D013274	Stomach Neoplasms

Ancestor Terms

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided