Safety and Efficiency of IRE Plus γδ T Cell Against Locally Advanced Pancreatic Cancer
Primary Purpose
Pancreatic Cancer
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
IRE surgery
IRE plus γδ T cells
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring Immunotherapy, γδ T Cell, Pancreatic Cancer
Eligibility Criteria
Inclusion Criteria:
- age: >18 years
- participants older than 18 years with either LAPC according to the American Joint Committee on Cancer (AJCC) criteria or isolated local recurrence with a maximum tumor diameter of 5 cm were considered eligible after pathologic confirmation
- will receive IRE, gd Tcells
- life expectancy: more than 3 months
- ability to understand the study protocol and a willingness to sign a written informed consent document
- adequate liver and renal function were required
- intolerant or refused to chemotherapy or to chemotherapy
Exclusion Criteria:
- patients with other kinds of cancer
- history of coagulation disorders or anemia
- heart disease and diabetes
- history of epilepsy, severe coronary disease, a history of level 3 hypertension,myelosuppression, autoimmune disease
- a performance status score of >2
Sites / Locations
- Biotherapy center in Fuda cancer hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Group A
Group B
Arm Description
In this group, the patients will receive IRE surgery to control the local tumor under CT .
In this group, the patients will receive multiple high-activity γδ T cell immunotherapies and IRE surgery
Outcomes
Primary Outcome Measures
PFS
PFS was defined as the interval between treatment initiation and local relapse
OS
OS was calculated as the interval from treatment initiation to death.
Secondary Outcome Measures
Tumor size
The tumor responses of the enrolled patients were assessed by CT in accordance with RECIST v1.1.Institute Common Terminology Criteria for Adverse Events (v4.0).
CTC
The absolute number of CD45-CK+ CD326+ cells was used to quantitate the CTC levels.
CA 19-9
The serum concentrations of CA19-9 were evaluated by a chemiluminescent immunoassay before treatment and 90 days after treatment.
Full Information
NCT ID
NCT03180437
First Posted
May 19, 2017
Last Updated
October 29, 2020
Sponsor
Fuda Cancer Hospital, Guangzhou
Collaborators
Jinan University Guangzhou
1. Study Identification
Unique Protocol Identification Number
NCT03180437
Brief Title
Safety and Efficiency of IRE Plus γδ T Cell Against Locally Advanced Pancreatic Cancer
Official Title
Safety and Efficiency of IRE Plus γδ T Cell Against Locally Advanced Pancreatic 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
June 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 Pancreatic Cancer in combination with tumor reducing surgery, for example IRE going to be investigated.
Detailed Description
Pancreatic tumor will be removed using tumor reducing surgery such as IRE. PBMC of the healthy donor will be separated from peripheral blood. After making them potential cancer killer γδ T Cell, they will be infused to the patients as an immunotherapy treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
Immunotherapy, γδ T Cell, Pancreatic Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Active Comparator
Arm Description
In this group, the patients will receive IRE surgery to control the local tumor under CT .
Arm Title
Group B
Arm Type
Experimental
Arm Description
In this group, the patients will receive multiple high-activity γδ T cell immunotherapies and IRE surgery
Intervention Type
Procedure
Intervention Name(s)
IRE surgery
Intervention Description
IRE surgery will be used in local tumor
Intervention Type
Biological
Intervention Name(s)
IRE plus γδ T cells
Intervention Description
Combination IRE surgery and γδ T cell will be used in Pancreatic Cancer
Primary Outcome Measure Information:
Title
PFS
Description
PFS was defined as the interval between treatment initiation and local relapse
Time Frame
2 years
Title
OS
Description
OS was calculated as the interval from treatment initiation to death.
Time Frame
2 year
Secondary Outcome Measure Information:
Title
Tumor size
Description
The tumor responses of the enrolled patients were assessed by CT in accordance with RECIST v1.1.Institute Common Terminology Criteria for Adverse Events (v4.0).
Time Frame
3 months
Title
CTC
Description
The absolute number of CD45-CK+ CD326+ cells was used to quantitate the CTC levels.
Time Frame
3 months
Title
CA 19-9
Description
The serum concentrations of CA19-9 were evaluated by a chemiluminescent immunoassay before treatment and 90 days after treatment.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age: >18 years
participants older than 18 years with either LAPC according to the American Joint Committee on Cancer (AJCC) criteria or isolated local recurrence with a maximum tumor diameter of 5 cm were considered eligible after pathologic confirmation
will receive IRE, gd Tcells
life expectancy: more than 3 months
ability to understand the study protocol and a willingness to sign a written informed consent document
adequate liver and renal function were required
intolerant or refused to chemotherapy or to chemotherapy
Exclusion Criteria:
patients with other kinds of cancer
history of coagulation disorders or anemia
heart disease and diabetes
history of epilepsy, severe coronary disease, a history of level 3 hypertension,myelosuppression, autoimmune disease
a performance status score of >2
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jibing Chen, PhD
Organizational Affiliation
Biological treatment center in Fuda cancer hospital Guangzhou
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
Citations:
PubMed Identifier
33093457
Citation
Lin M, Zhang X, Liang S, Luo H, Alnaggar M, Liu A, Yin Z, Chen J, Niu L, Jiang Y. Irreversible electroporation plus allogenic Vgamma9Vdelta2 T cells enhances antitumor effect for locally advanced pancreatic cancer patients. Signal Transduct Target Ther. 2020 Oct 23;5(1):215. doi: 10.1038/s41392-020-00260-1.
Results Reference
derived
Learn more about this trial
Safety and Efficiency of IRE Plus γδ T Cell Against Locally Advanced Pancreatic Cancer
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