Simultaneous Gemcitabine and Irreversible Electroporation for Locally Advanced Pancreatic Cancer
NCT ID: NCT02981719
Last Updated: 2021-01-22
Study Results
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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COMPLETED
NA
61 participants
INTERVENTIONAL
2016-10-01
2020-10-01
Brief Summary
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Detailed Description
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In the IRE group, the IRE ablation was performed without gemcitabine intravenous infusion before IRE.
The aim of this study was to evslusted the overall survival (OS), objective response rate (ORR) and adverse events after simultaneous therapy.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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simultaneous gemcitabine and irreversible electroporation
gemcitabine intravenous infusion prior to irreversible electroporation treatment.
simultaneous gemcitabine and irreversible electroporation
gemcitabine intravenous infusion prior to irreversible electroporation treatment
IRE group
percutaneous irreversible electroporation for locally advanced pancreatic cancer.
irreversible electroporation
percutaneous irreversible electroporation was performmed for locally advaanced pancreatic cancer.
Interventions
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simultaneous gemcitabine and irreversible electroporation
gemcitabine intravenous infusion prior to irreversible electroporation treatment
irreversible electroporation
percutaneous irreversible electroporation was performmed for locally advaanced pancreatic cancer.
Eligibility Criteria
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Inclusion Criteria
* Screening must be performed no longer than 2 weeks prior to study inclusion
* Maximum tumor diameter ≤ 5 cm
* Histological or cytological confirmation of pancreatic adenocarcinoma;
* Age ≥ 18 years
* PS-classification 0 - 2
* Life expectancy of at least 12 weeks
* Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to definite inclusion;
* Hemoglobin level ≥ 115 g/L
* Platelet count ≥ 100\*109/l
* Neutrophil count ≥ 2×109/L;
* White blood cell count ≥ 4 ×109/L;
* ALT and AST ≤ 2.5 x ULN
* Serum creatinine ≤ 1.5 x ULN or a calculated creatinine clearance ≥ 50 ml/min
* Prothrombin time or INR \< 1.5 x ULN
* Written informed consent
Exclusion Criteria
* History of epilepsy
* History of cardiac disease:
* Cardiac arrhythmias requiring anti-arrhythmic therapy or pacemaker (beta blockers for antihypertensive regimen are permitted)
* Compromised liver function (e.g. signs of portal hypertension, INR \> 1,5 without use of anticoagulants, ascites)
* Uncontrolled infections (\> grade 2 NCI-CTC version 3.0)
* Pregnant. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment
* Allergy to contrast media
* Any implanted stimulation device
* Any implanted metal stent/device within the area of ablation that cannot be removed
18 Years
80 Years
ALL
No
Sponsors
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Fuda Cancer Hospital, Guangzhou
OTHER
Responsible Party
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Principal Investigators
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Lizhi Niu, PHD
Role: STUDY_CHAIR
Fuda Cancer Hospital
Locations
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FUDA Cancer Hospital
Guangzhou, Guangdong, China
Countries
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Other Identifiers
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Y2016-MS-001
Identifier Type: -
Identifier Source: org_study_id
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