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2016-03-01
2017-03-01
2019-03-01
60
NCT02718859
Fuda Cancer Hospital, Guangzhou
Fuda Cancer Hospital, Guangzhou
INTERVENTIONAL
Combination of Irreversible Electroporation and NK Immunotherapy 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.
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
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2016-03-09 | N/A | 2019-09-10 |
2016-03-19 | N/A | 2019-09-12 |
2016-03-24 | N/A | 2019-03 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| ACTIVE_COMPARATOR: irreversible electroporation (IRE) Advanced pancreatic cancer patients received only irreversible electroporation (IRE) without immunotherapy | PROCEDURE: irreversible electroporation (IRE )
|
| EXPERIMENTAL: IRE & NK cells Advanced pancreatic cancer patients received both irreversible electroporation (IRE ) and immunotherapy of nature killer(NK) cells | BIOLOGICAL: NK cells
PROCEDURE: irreversible electroporation (IRE )
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Relief degree | It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST） | 1 year |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Progress free survival（PFS） | 1 year | |
| Overall survival（OS） | 3 year |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
