Pancreatic CancerPhase 1/2NCT02718859
Combination of Irreversible Electroporation and NK Immunotherapy for Advanced Pancreatic Cancer
A Phase 1/2 study testing NK cells and irreversible electroporation (IRE ) in people with Pancreatic Cancer, run by Fuda Cancer Hospital, Guangzhou at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of the combined therapy using irreversible electroporation（IRE）and nature killer(NK) cells for advanced pancreatic cancer. 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?
- NK cells and irreversible electroporation (IRE )
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2016to 1 Mar 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:18-80
- Diagnosis：advanced and active pancreatic cancer
- The tumour is measurable
- Eastern Cooperative Oncology Group(ECOG) score：0~2；3 but has no relationship with tumour
- Vital organ function is normal:
- total bilirubin(TB) <68μmol/L aspartate aminotransferase(AST)<90 IU/L Cre<353μmol/L white blood cell count(WBC)<9×10^9/L,when WBC is close to or even greater than 9×10^9/L，the recommended dose should be halved platelet count(PLT)>80×10^9/L Red blood cell specific volume(HCT)>0.20 Non severe viral or bacterial infection
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- Non pregnant and lactating patients
- Non allergic reactions to biological products
- Informed and consent
Who cannot join
- Patients with cardiac pacemaker
- Patients with severe cardiac and pulmonary dysfunction
- Patients that the researchers do not think fit into the group,including patients failed in compliance assessment
Trial locations and contacts
1 site in 1 country.
China1 site
Central laboratory in Fuda cancer hospital
Guangzhou, Guangdong, 510000
About this study
Official title: Study of the Combined Therapy of Irreversible Electroporation（IRE） and Nature Killer (NK) Cells for Advanced Pancreatic Cancer
The purpose of this study is to evaluate the safety and efficacy of the combined therapy using irreversible electroporation（IRE）and nature killer(NK) cells for advanced pancreatic cancer.
Read the detailed description
By enrolling patients with pancreatic cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of the combined therapy using irreversible electroporation（IRE）and nature killer（NK） cells for advanced pancreatic cancer.
The efficacy will be evaluated according to relief degree,progress free survival(PFS) and overall survival(OS).
The safety will be evaluated by statistics of adverse reaction
- Conditions
- Pancreatic Cancer
- Being tested
- NK cells, irreversible electroporation (IRE )
- Keywords
- advanced pancreatic cancer, nature killer cell, irreversible electroporation
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NK cellsBiological
The pancreatic cancer patients will receive nature killer(NK) cells infusions,qd
irreversible electroporation (IRE )Procedure or surgery
The pancreatic cancer patients will receive the therapy of irreversible electroporation (IRE )
| Study group | Role | What they receive |
|---|---|---|
| irreversible electroporation (IRE) | Active comparator | Advanced pancreatic cancer patients received only irreversible electroporation (IRE) without immunotherapy Receives: Procedure: irreversible electroporation (IRE ) |
| IRE & NK cells | Experimental | Advanced pancreatic cancer patients received both irreversible electroporation (IRE ) and immunotherapy of nature killer(NK) cells Receives: Biological: NK cells; Procedure: irreversible electroporation (IRE ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relief degree
It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST）
Measured: 1 year
Secondary outcomes (2)
Progress free survival（PFS）
Measured: 1 year
Overall survival（OS）
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2016 (estimated)
- Study start1 Mar 2016
- Primary completion1 Mar 2017
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fuda Cancer Hospital, Guangzhou
- Sponsor type
- University, hospital or other
- Collaborators
- Shenzhen Hank Bioengineering Institute
- Responsible party
- Sponsor
- Investigators
- Lizhi Niu, PhD, Study chair, Fuda Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02718859
- Sponsor's protocol ID
- NK-pancre
- Status last verified
- Mar 2019
- First submitted
- 9 Mar 2016
- Last updated
- 12 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Combined Therapy of Irreversible Electroporation（IRE） and Nature Killer (NK) Cells for Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT02718859
- Acronym / sponsor ID
- NK-pancre
- Conditions
- Pancreatic Cancer
- Keywords
- advanced pancreatic cancer, nature killer cell, irreversible electroporation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Fuda Cancer Hospital, GuangzhouUniversity, hospital or other
- Collaborators
- Shenzhen Hank Bioengineering Institute
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 1 Mar 2017 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 24 Mar 2016 (estimated)
- 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.
The purpose of this study is to evaluate the safety and efficacy of the combined therapy using irreversible electroporation（IRE）and nature killer(NK) cells for advanced pancreatic cancer.
Detailed description
By enrolling patients with pancreatic cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of the combined therapy using irreversible electroporation（IRE）and nature killer（NK） cells for advanced pancreatic cancer.
The efficacy will be evaluated according to relief degree,progress free survival(PFS) and overall survival(OS).
The safety will be evaluated by statistics of adverse reaction
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| irreversible electroporation (IRE) | Active comparator | Procedure: irreversible electroporation (IRE )Advanced pancreatic cancer patients received only irreversible electroporation (IRE) without immunotherapy |
| IRE & NK cells | Experimental | Biological: NK cells, Procedure: irreversible electroporation (IRE )Advanced pancreatic cancer patients received both irreversible electroporation (IRE ) and immunotherapy of nature killer(NK) cells |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age:18-80
- Diagnosis：advanced and active pancreatic cancer
- The tumour is measurable
- Eastern Cooperative Oncology Group(ECOG) score：0~2；3 but has no relationship with tumour
- Vital organ function is normal:
Key exclusion criteria (3 listed)
- Patients with cardiac pacemaker
- Patients with severe cardiac and pulmonary dysfunction
- Patients that the researchers do not think fit into the group,including patients failed in compliance assessment
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 |
|---|---|---|
| NK cellsThe pancreatic cancer patients will receive nature killer(NK) cells infusions,qd | Biological | IRE & NK cells |
| irreversible electroporation (IRE )The pancreatic cancer patients will receive the therapy of irreversible electroporation (IRE ) | Procedure or surgery | IRE & NK cells, irreversible electroporation (IRE) |
Primary outcome
Relief degree
Time frame: 1 year
It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST）
2 secondary outcomes
Progress free survival（PFS）
Time frame: 1 year
Overall survival（OS）
Time frame: 3 year
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 12 Sep 2019.
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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.
Lizhi Niu, PhD study chair
Fuda Cancer Hospital
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 NK cells and irreversible electroporation (IRE ) 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 9 inclusion and 3 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 12 Sep 2019. 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?
Relief degree (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Sep 2019.