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NCT02425735 Clinical Trial

Safety and Efficiency of γδ T Cell Against Hepatocellular Liver Cancer

Liver Cancer Clinical Trial

Official title:
γδ T Cell Immunotherapy for Treatment of Hepatocellular Liver Cancer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02425735
Other study ID # Gd T cell and Hepatocellular
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received April 21, 2015
Last updated July 17, 2016
Start date April 2015
Est. completion date June 2016

Study information
Verified date April 2015
Source Fuda Cancer Hospital, Guangzhou
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

In this study, effects of γδT cells on human hepatocellular liver cancer in combination with tumor reducing surgery, for example cryosurgery going to be investigated.

Description:

Liver tumor will be removed using tumor reducing surgery such as cryosurgery. PBMC of the patient will be separated from peripheral blood. After making them potential cancer killer γδ T Cell and DC-CIK, they will be infused to the patients as an immunotherapy treatment.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date June 2016
Est. primary completion date June 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

1. Age:18-75

2. Karnofsky performance status >50

3. Diagnosis with hepatocellular carcinoma cancer based on histology or the current accepted radiological measures.

4. Classification tumor,nodes,metastasis-classification(TNM) stage: ?,?,?

5. Will receive cryosurgery, gd Tcells/ DC-CIK.

6. Life expectancy: Greater than 3 months

7. Ability to understand the study protocol and a willingness to sign a written informed consent document

Exclusion Criteria:

1. Patients with other kinds of cancer

2. History of coagulation disorders or anemia

3. Patients with heart disease and diabetes

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Biological:
• DC-CIK cells
DC-CIK cells will be used against tumor cells.
• ?d T cells
?d T cells will be used against breast tumor.
• ?d T/DC-CIK cells
?d T/DC-CIK cells will be used against breast tumor.

Locations
Country Name City State
China Biological treatment center in Fuda cancer hospital Guangzhou Guangdong

Sponsors (2)
Lead Sponsor Collaborator
Fuda Cancer Hospital, Guangzhou Jinan University Guangzhou

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Reduced size of the tumors Up to one year Yes
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