Anti-Tumor Immunity Induced by IRE of Unresectable Pancreatic Cancer
NCT ID: NCT02343835
Last Updated: 2021-09-05
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
20 participants
INTERVENTIONAL
2015-01-01
2021-05-01
Brief Summary
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Detailed Description
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After IRE, patients will be carefully monitored and systemic immune responses are registered. Follow-up will consist of frequent CT and MRI scanning, as well as serum CA19.9 tumor marker and quality of life questionnaires and overall survival (OS).
The investigators hypothesize that IRE in the pancreas will induce good symptom palliation without causing severe complications as well as perfect systemic immune response.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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NanoKnife LEDC System
90 pulses of 70 microseconds each in duration will be administered per electrode pair.
NanoKnife LEDC System
Irreversible electroporation (IRE) is a new, minimal-invasive image-guided treatment method for tumors not amenable for surgical resection or thermal ablation, due to vicinity near vital structures such as vessels and bile ducts. With IRE, multiple electrical pulses are applied to tumorous tissue. These pulses alter the existing transmembrane potential of the cell membranes, and create 'nanopores', after which the cell dies through loss of homeostasis.
Control
The patients without treatment
No interventions assigned to this group
Interventions
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NanoKnife LEDC System
Irreversible electroporation (IRE) is a new, minimal-invasive image-guided treatment method for tumors not amenable for surgical resection or thermal ablation, due to vicinity near vital structures such as vessels and bile ducts. With IRE, multiple electrical pulses are applied to tumorous tissue. These pulses alter the existing transmembrane potential of the cell membranes, and create 'nanopores', after which the cell dies through loss of homeostasis.
Other Intervention Names
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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;
* ASA-classification 0 - 3
* 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 ≥ 5.6 mmol/L;
* Absolute neutrophil count (ANC) ≥ 1,500/mm3;
* Platelet count ≥ 100\*109/l;
* Total bilirubin ≤ 1.5 times the upper limit of normal (ULN);
* 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;
* Activated partial thromboplastin time \< 1.25 x ULN (therapeutic anticoagulation therapy is allowed if this treatment can be interrupted as judged by the treating physician);
* Written informed consent;
Exclusion Criteria
* Successful down staging after (radio)chemotherapy from previous unresectable/borderline tumor to resectable tumor;
* History of epilepsy;
* History of cardiac disease:
* Congestive heart failure \>NYHA class 2;
* Active Coronary Artery Disease (defined as myocardial infarction within 6 months prior to screening);
* Cardiac arrhythmias requiring anti-arrhythmic therapy or pacemaker (beta blockers for antihypertensive regimen are permitted);
* Uncontrolled hypertension. Blood pressure must be ≤160/95 mmHg at the time of screening on a stable antihypertensive regimen;
* 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;
* Immunotherapy ≤ 6 weeks prior to the procedure;
* Chemotherapy ≤ 6 weeks prior to the procedure;
* Radiotherapy ≤ 6 weeks prior to the procedure;
* Concomitant use of anti-convulsive and anti-arrhythmic drugs (other than beta blockers used for antihypertensive);
* Allergy to contrast media;
* Any implanted stimulation device;
* Any implanted metal stent/device within the area of ablation that cannot be removed;
* Any condition that is unstable or that could jeopardize the safety of the subject and their compliance in the study; Of note, patients with contra-indications for MRI will not be excluded from participation: in this case radiologic follow-up will consist of CT-scanning according to protocol.
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 l Niu, M.D.,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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JF-20150113(4)
Identifier Type: -
Identifier Source: org_study_id
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