Safety and Efficacy of γδ T Cell Against Gastric Cancer

November 11, 2019 updated by: Beijing Doing Biomedical Co., Ltd.

γδ T Cell Immunotherapy for Treatment of Gastric Cancer

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • The First Affiliated Hospital of Guangzhou Medical University
    • Henan
      • Luoyang, Henan, China, 471003
        • First Affiliated Hospital of Henan University of Science and Technology
    • Jiangsu
      • Huaian, Jiangsu, China, 223300
        • Huai'an first people's hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310002
        • Hangzhou Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Experimental Group A(control group)
regular treatment and follow up
Experimental: Experimental Group B
CIK will be used against tumor cells.
Biological: CIK
CIK cells will be used against tumor cells.
Experimental: Experimental Group C
γδ T will be used against tumor cells.
Biological: γδ T
γδ T cells will be used against tumor cells.
Experimental: Experimental Group D
CIK and γδ T will be used against tumor cells.
Biological: CIK and γδ T
CIK and γδ T cells will be used against tumor cells.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Doing Biomedical Co., Ltd.

Investigators

  • Study Chair: Li gangyi, master, Beijing Doing Biomedical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2019

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

October 22, 2015

First Submitted That Met QC Criteria

October 22, 2015

First Posted (Estimate)

October 26, 2015

Study Record Updates

Last Update Posted (Actual)

November 13, 2019

Last Update Submitted That Met QC Criteria

November 11, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Doing-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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