Simultaneous Gemcitabine and Irreversible Electroporation for Locally Advanced Pancreatic Cancer

Study Overview
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Brief Summary
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The aim of this study was to compare the therapeutic efficacy between simultaneous gemcitabine administration and IRE and IRE alone for locally advanced pancreatic cancer (LAPC)

Detailed Description
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in the GEM- IRE group, before the IRE ablation started, patients received 1000 mg/m2 gemcitabine hydrochloride [Qilu pharmaceutical (Hainan) Co., Ltd. Haikou, China] intravenously (over approximately 30 min). 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.

Official Title
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Simultaneous Gemcitabine and Irreversible Electroporation for Locally Advanced Pancreatic Cancer

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Procedure: simultaneous gemcitabine and irreversible electroporation
* Procedure: irreversible electroporation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Radiologic confirmation of unresectable locally advanced pancreatic cancer by at least CT of chest and abdomen 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: Resectable pancreatic adenocarcinoma as discussed by our multidisciplinary hepatobiliary team 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: simultaneous gemcitabine and irreversible electroporation<br>gemcitabine intravenous infusion prior to irreversible electroporation treatment. | Procedure: simultaneous gemcitabine and irreversible electroporation<br>* gemcitabine intravenous infusion prior to irreversible electroporation treatment<br>|
| Other: IRE group<br>percutaneous irreversible electroporation for locally advanced pancreatic cancer. | Procedure: irreversible electroporation<br>* percutaneous irreversible electroporation was performmed for locally advaanced pancreatic cancer.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (number of adverse effects) | Adverse events | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor response | Imaging evaluation | 12 months | 
| Overall survival (OS) | Overall survival (OS) was defined using time of death. | 36 months | 
| Carbohydrate antigen 19-9 (CA19-9) | carbohydrate antigen 19-9 (CA19-9) levels were measured. | 1 month | 
| Technical success of ablation | The technical success addressed whether the tumor was treated according to protocol and was covered completely by the ablation zone. | 3 months |