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Safety and Efficiency of IRE Plus γδ T Cell Against Locally Advanced Pancreatic Cancer

NCT ID: NCT03180437

Last Updated: 2020-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-15

Study Completion Date

2019-06-15

Brief Summary

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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

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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.

Conditions

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Pancreatic Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A

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

Group Type ACTIVE_COMPARATOR

IRE surgery

Intervention Type PROCEDURE

IRE surgery will be used in local tumor

Group B

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

Group Type EXPERIMENTAL

IRE plus γδ T cells

Intervention Type BIOLOGICAL

Combination IRE surgery and γδ T cell will be used in Pancreatic Cancer

Interventions

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IRE surgery

IRE surgery will be used in local tumor

Intervention Type PROCEDURE

IRE plus γδ T cells

Combination IRE surgery and γδ T cell will be used in Pancreatic Cancer

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jinan University Guangzhou

OTHER

Sponsor Role collaborator

Fuda Cancer Hospital, Guangzhou

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jibing Chen, PhD

Role: PRINCIPAL_INVESTIGATOR

Biological treatment center in Fuda cancer hospital Guangzhou

Locations

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Biotherapy center in Fuda cancer hospital

Guangzhou, Guangdong, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 33093457 (View on PubMed)

Other Identifiers

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Gd T cell and Pancreatic Ca

Identifier Type: -

Identifier Source: org_study_id