Pancreatic CancerPhase 1/2NCT03180437
Safety and Efficiency of IRE Plus γδ T Cell Against Locally Advanced Pancreatic Cancer
A Phase 1/2 study testing IRE surgery and IRE plus γδ T cells in people with Pancreatic Cancer, run by Fuda Cancer Hospital, Guangzhou at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- IRE surgery and IRE plus γδ T cells
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2017to 15 Jun 2019
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Biotherapy center in Fuda cancer hospital
Guangzhou, Guangdong, 510665
About this study
In this study, effects of γδT cells on human Pancreatic Cancer in combination with tumor reducing surgery, for example IRE going to be investigated.
Read the 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.
- Conditions
- Pancreatic Cancer
- Being tested
- IRE surgery, IRE plus γδ T cells
- Keywords
- Immunotherapy, γδ T Cell, Pancreatic Cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IRE surgeryProcedure or surgery
IRE surgery will be used in local tumor
IRE plus γδ T cellsBiological
Combination IRE surgery and γδ T cell will be used in Pancreatic Cancer
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | In this group, the patients will receive IRE surgery to control the local tumor under CT . Receives: Procedure: IRE surgery |
| Group B | Experimental | In this group, the patients will receive multiple high-activity γδ T cell immunotherapies and IRE surgery Receives: Biological: IRE plus γδ T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
PFS was defined as the interval between treatment initiation and local relapse
Measured: 2 years
OS
OS was calculated as the interval from treatment initiation to death.
Measured: 2 year
Secondary outcomes (3)
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).
Measured: 3 months
CTC
The absolute number of CD45-CK+ CD326+ cells was used to quantitate the CTC levels.
Measured: 3 months
CA 19-9
The serum concentrations of CA19-9 were evaluated by a chemiluminescent immunoassay before treatment and 90 days after treatment.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2017
- Study start15 Jun 2017
- Primary completion15 Jun 2018
- Study completion15 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fuda Cancer Hospital, Guangzhou
- Sponsor type
- University, hospital or other
- Collaborators
- Jinan University Guangzhou
- Responsible party
- Sponsor
- Investigators
- Jibing Chen, PhD, Principal investigator, Biological treatment center in Fuda cancer hospital Guangzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03180437
- Sponsor's protocol ID
- Gd T cell and Pancreatic Ca
- Status last verified
- Jul 2020
- First submitted
- 19 May 2017
- Last updated
- 2 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33093457
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficiency of IRE Plus γδ T Cell Against Locally Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT03180437
- Acronym / sponsor ID
- Gd T cell and Pancreatic Ca
- Conditions
- Pancreatic Cancer
- Keywords
- Immunotherapy, γδ T Cell, Pancreatic Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Fuda Cancer Hospital, GuangzhouUniversity, hospital or other
- Collaborators
- Jinan University Guangzhou
- Study start
- 15 Jun 2017 (actual)
- Primary completion
- 15 Jun 2018 (actual)
- Study completion
- 15 Jun 2019 (actual)
- First posted
- 8 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Procedure: IRE surgeryIn this group, the patients will receive IRE surgery to control the local tumor under CT . |
| Group B | Experimental | Biological: IRE plus γδ T cellsIn this group, the patients will receive multiple high-activity γδ T cell immunotherapies and IRE surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IRE surgeryIRE surgery will be used in local tumor | Procedure or surgery | Group A |
| IRE plus γδ T cellsCombination IRE surgery and γδ T cell will be used in Pancreatic Cancer | Biological | Group B |
Primary outcome
PFS
Time frame: 2 years
PFS was defined as the interval between treatment initiation and local relapse
OS
Time frame: 2 year
OS was calculated as the interval from treatment initiation to death.
3 secondary outcomes
Tumor size
Time frame: 3 months
CTC
Time frame: 3 months
CA 19-9
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2020.
- Derived from this study: PubMed 33093457Lin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jibing Chen, PhD principal investigator
Biological treatment center in Fuda cancer hospital Guangzhou
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IRE surgery and IRE plus γδ T cells in people with Pancreatic Cancer, run by Fuda Cancer Hospital, Guangzhou at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03180437, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2020.