NCT02425735

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

April 21, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 24, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

July 19, 2016

Status Verified

April 1, 2015

Enrollment Period

1.2 years

First QC Date

April 21, 2015

Last Update Submit

July 17, 2016

Conditions

Liver Cancer

Keywords

Immunotherapy, γδ T Cell, heptocellular liver cancer

Outcome Measures

Primary Outcomes (1)

  • Reduced size of the tumors

    Up to one year

Study Arms (3)

Group A

EXPERIMENTAL

DC-CIK cells will be used against tumor cells.

Biological: DC-CIK cells

Group B

EXPERIMENTAL

γδ T cells will be used against tumor cells.

Biological: γδ T cells

Group C

EXPERIMENTAL

Combination of γδ T cells/ DC-CIK be used against tumor cells.

Biological: γδ T/DC-CIK cells

Interventions

DC-CIK cellsBIOLOGICAL

DC-CIK cells will be used against tumor cells.

Group A
γδ T cellsBIOLOGICAL

γδ T cells will be used against breast tumor.

Group B
γδ T/DC-CIK cellsBIOLOGICAL

γδ T/DC-CIK cells will be used against breast tumor.

Group C

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age:18-75
  • Karnofsky performance status \>50
  • Diagnosis with hepatocellular carcinoma cancer based on histology or the current accepted radiological measures.
  • Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ
  • Will receive cryosurgery, gd Tcells/ DC-CIK.
  • Life expectancy: Greater than 3 months
  • Ability to understand the study protocol and a willingness to sign a written informed consent document

You may not qualify if:

  • Patients with other kinds of cancer
  • History of coagulation disorders or anemia
  • Patients with heart disease and diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biological treatment center in Fuda cancer hospital

Guangzhou, Guangdong, 510000, China

Location

Related Publications (1)

  • Alnaggar M, Xu Y, Li J, He J, Chen J, Li M, Wu Q, Lin L, Liang Y, Wang X, Li J, Hu Y, Chen Y, Xu K, Wu Y, Yin Z. Allogenic Vgamma9Vdelta2 T cell as new potential immunotherapy drug for solid tumor: a case study for cholangiocarcinoma. J Immunother Cancer. 2019 Feb 8;7(1):36. doi: 10.1186/s40425-019-0501-8.

    PMID: 30736852DERIVED

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2015

First Posted

April 24, 2015

Study Start

April 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

July 19, 2016

Record last verified: 2015-04

Locations

CN(1)