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Safety and Efficiency of γδ T Cell Against Liver Cancer

Primary Purpose

Liver Cancer

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Cryosurgery or IRE surgery
γδ T cell
γδ T cells/ A Cryosurgery or IRE
Sponsored by
Fuda Cancer Hospital, Guangzhou
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cancer focused on measuring Immunotherapy, γδ T Cell, Liver Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age: 18-75
  2. Karnofsky performance status >50
  3. Diagnosis with Liver Cancer based on histology or the current accepted radiological measures
  4. Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ
  5. Will receive cryosurgery, IRE, gd T cells
  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

Sites / Locations

  • Biotherapy center in Fuda cancer hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Group A

Group B

Group C

Arm Description

In this group, the patients will receive under CT Cryosurgery or IRE surgery to control the local tumor.

In this group, the patients will receive multiple high-activity γδ T cell immunotherapies. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).

In this group, the patients will receive multiple high-activity γδ T cell immunotherapies and Cryosurgery or IRE surgery

Outcomes

Primary Outcome Measures

Relief degree of tumors
It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST）
Progress free survival（PFS）
Overall survival（OS）

Secondary Outcome Measures

Full Information

First Posted
June 8, 2017
Last Updated
July 10, 2020
Sponsor
Fuda Cancer Hospital, Guangzhou
Collaborators
Jinan University Guangzhou
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1. Study Identification

Unique Protocol Identification Number
NCT03183219
Brief Title
Safety and Efficiency of γδ T Cell Against Liver Cancer
Official Title
γδ T Cell Immunotherapy for Treatment of Liver Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
June 15, 2017 (Actual)
Primary Completion Date
January 15, 2018 (Actual)
Study Completion Date
June 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fuda Cancer Hospital, Guangzhou
Collaborators
Jinan University Guangzhou

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
In this study, effects of γδT cells on human Liver Cancer in combination with tumor reducing surgery, for example, cryosurgery going to be investigated.
Detailed Description
A 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. NOTE: Originally, our designed proposal was to use autologous PBMCs from cancer patients to ex vivo expand Vγ9Vδ2-T cells, and then perform adoptive transfer therapy. However, PBMCs of majority of cancer patients could not be effectively expanded, including cell number, cell purity and cell function could not meet the requirements of reinfusion. Meanwhile, those patients could not tolerate 100ml of blood drawing for culture every 2 ~ 3 weeks. Therefore, we submitted new clinical study application to the ethical committee of the Fuda Hospital affiliated with Jinan University (Guangzhou, PR. China) by changing the autologous protocol with the allogeneic protocol. After the allogeneic protocol was approved, we adapted allogeneic cells instead of autologous in our subsequentially clinical study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer
Keywords
Immunotherapy, γδ T Cell, Liver Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
In this group, the patients will receive under CT Cryosurgery or IRE surgery to control the local tumor.
Arm Title
Group B
Arm Type
Experimental
Arm Description
In this group, the patients will receive multiple high-activity γδ T cell immunotherapies. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).
Arm Title
Group C
Arm Type
Experimental
Arm Description
In this group, the patients will receive multiple high-activity γδ T cell immunotherapies and Cryosurgery or IRE surgery
Intervention Type
Procedure
Intervention Name(s)
Cryosurgery or IRE surgery
Intervention Description
Cryosurgery or IRE surgery will be used in local tumor
Intervention Type
Biological
Intervention Name(s)
γδ T cell
Intervention Description
γδ T cells will be used against Liver Cancer
Intervention Type
Other
Intervention Name(s)
γδ T cells/ A Cryosurgery or IRE
Intervention Description
Combination γδ T cell and Cryosurgery or IRE surgery will be used in Liver Cancer
Primary Outcome Measure Information:
Title
Relief degree of tumors
Description
It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST）
Time Frame
3 months
Title
Progress free survival（PFS）
Time Frame
1 year
Title
Overall survival（OS）
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age: 18-75 Karnofsky performance status >50 Diagnosis with Liver Cancer based on histology or the current accepted radiological measures Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ Will receive cryosurgery, IRE, gd T cells Life expectancy: Greater than 3 months Ability to understand the study protocol and a willingness to sign a written informed consent document Exclusion Criteria: Patients with other kinds of cancer History of coagulation disorders or anemia Patients with heart disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jibing Chen, PhD
Organizational Affiliation
Biological treatment center in Fuda cancer hospital Guangzhou, Guangdong, China, 510000
Official's Role
Principal Investigator
Facility Information:
Facility Name
Biotherapy center in Fuda cancer hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510665
Country
China

12. IPD Sharing Statement

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Safety and Efficiency of γδ T Cell Against Liver Cancer

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