Safety and Efficacy of γδ T Cell Against Gastric Cancer
γδ T Cell Immunotherapy for Treatment of Gastric Cancer
1 other identifier
interventional
120
1 country
4
Brief Summary
In this study, safety and effects of γδT cells on human gastric cancer are going to be investigated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 gastric-cancer
Started Dec 2019
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 22, 2015
CompletedFirst Posted
Study publicly available on registry
October 26, 2015
CompletedStudy Start
First participant enrolled
December 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedNovember 13, 2019
September 1, 2019
2 years
October 22, 2015
November 11, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Reduced size of the tumor.
Tumor load will be evaluated by RECIST criteria.
up to one year
Secondary Outcomes (1)
Safety, as measured by the rate of adverse events and serious adverse events
up to two years
Study Arms (4)
Experimental Group A(control group)
NO INTERVENTIONregular treatment and follow up
Experimental Group B
EXPERIMENTALCIK will be used against tumor cells.
Experimental Group C
EXPERIMENTALγδ T will be used against tumor cells.
Experimental Group D
EXPERIMENTALCIK and γδ T will be used against tumor cells.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120, China
First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 471003, China
Huai'An First People'S Hospital
Huaian, Jiangsu, 223300, China
Hangzhou Cancer Hospital
Hangzhou, Zhejiang, 310002, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
li gangyi, master
Beijing Doing Biomedical Co., Ltd.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 22, 2015
First Posted
October 26, 2015
Study Start
December 1, 2019
Primary Completion
December 1, 2021
Study Completion
December 1, 2022
Last Updated
November 13, 2019
Record last verified: 2019-09