Safety and Efficiency of IRE Plus γδ T Cell Against Locally Advanced Pancreatic Cancer
1 other identifier
interventional
62
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 pancreatic-cancer
Started Jun 2017
Shorter than P25 for phase_1 pancreatic-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 19, 2017
CompletedFirst Posted
Study publicly available on registry
June 8, 2017
CompletedStudy Start
First participant enrolled
June 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 15, 2019
CompletedNovember 2, 2020
July 1, 2020
1 year
May 19, 2017
October 29, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
PFS
PFS was defined as the interval between treatment initiation and local relapse
2 years
OS
OS was calculated as the interval from treatment initiation to death.
2 year
Secondary Outcomes (3)
Tumor size
3 months
CTC
3 months
CA 19-9
3 months
Study Arms (2)
Group A
ACTIVE COMPARATORIn this group, the patients will receive IRE surgery to control the local tumor under CT .
Group B
EXPERIMENTALIn this group, the patients will receive multiple high-activity γδ T cell immunotherapies and IRE surgery
Interventions
Combination IRE surgery and γδ T cell will be used in Pancreatic Cancer
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fuda Cancer Hospital, Guangzhoulead
- Jinan University Guangzhoucollaborator
Study Sites (1)
Biotherapy center in Fuda cancer hospital
Guangzhou, Guangdong, 510665, China
Related Publications (1)
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.
PMID: 33093457DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jibing Chen, PhD
Biological treatment center in Fuda cancer hospital Guangzhou
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2017
First Posted
June 8, 2017
Study Start
June 15, 2017
Primary Completion
June 15, 2018
Study Completion
June 15, 2019
Last Updated
November 2, 2020
Record last verified: 2020-07