Clinical trial · Interventional
Simultaneous Gemcitabine and Irreversible Electroporation for Locally Advanced Pancreatic Cancer
NCT02981719CI-TRIAL-00049574completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| irreversible electroporation | Procedure | — | UNRESOLVED |
| simultaneous gemcitabine and irreversible electroporation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- simultaneous gemcitabine and irreversible electroporation
- description
- gemcitabine intravenous infusion prior to irreversible electroporation treatment.
- interventionNames
- Procedure: simultaneous gemcitabine and irreversible electroporation
- type
- OTHER
- label
- IRE group
- description
- percutaneous irreversible electroporation for locally advanced pancreatic cancer.
- interventionNames
- Procedure: irreversible electroporation
Primary outcomes (1)
- measure
- Safety (number of adverse effects)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.