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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
Fuda Cancer Hospital, Guangzhou
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. age: >18 years
  2. 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
  3. will receive IRE, gd Tcells
  4. life expectancy: more than 3 months
  5. ability to understand the study protocol and a willingness to sign a written informed consent document
  6. adequate liver and renal function were required
  7. intolerant or refused to chemotherapy or to chemotherapy

Exclusion Criteria:

  1. patients with other kinds of cancer
  2. history of coagulation disorders or anemia
  3. heart disease and diabetes
  4. history of epilepsy, severe coronary disease, a history of level 3 hypertension，myelosuppression, autoimmune disease
  5. 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

First Posted
May 19, 2017
Last Updated
October 29, 2020
Sponsor
Fuda Cancer Hospital, Guangzhou
Collaborators
Jinan University Guangzhou
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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
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Safety and Efficiency of IRE Plus γδ T Cell Against Locally Advanced Pancreatic Cancer

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