Clinical trial · Interventional
Chemotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma
Chemotherapy and Irreversible Electroporation (IRE) in the Treatment of Advanced Pancreatic Adenocarcinoma
NCT03484299CI-TRIAL-00096851recruitingPhase 1ClinicalTrials.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)
Compare the efficacy and tolerability of IRE in combination with either FOLFIRINOX or gemcitabine in patients with locally advanced pancreatic cancer.
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 |
|---|---|---|---|
| Pancreas Cancer | Pancreatic Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FOLFIRINOX | Drug | — | UNRESOLVED |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Irreversible Electroporation (IRE) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Treatment
- description
- Irreversible electroporation and treatment with either FOLFIRINOX or Gemcitabine (based upon which chemotherapy regimen received prior to IRE)
- interventionNames
- Procedure: Irreversible Electroporation (IRE)
- Drug: Gemcitabine
- Drug: FOLFIRINOX
Primary outcomes (1)
- measure
- Incidence of Adverse and Serious Adverse events will be captured (safety and tolerability)
- timeFrame
- Time from first dose until subject has reached 90 days post last active study treatment
- description
- Adverse and Serious Adverse events will be collected and analyzed
Secondary outcomes (1)
- measure
- Progression free survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * greater than or equal to 18 years of age * diagnosed with stage III pancreatic cancer * tumor is measurable * GFR \> mL/min/1.73m2 * willing and able to comply with protocol requirements * AST/ALT \>3 times upper limit of normal * stable surgical post-operative course as defined by operative surgeon Exclusion Criteria: * participating in another clinical trial for the treatment of cancer at the time of screening * pregnant or currently breast feeding * have a cardiac pacemaker or ICD implanted that cannot be deactivated during IRE procedure * have non-removable implants with metal parts within 1 cm of the target lesion * had a myocardial infarction within 3 months prior to enrollment
References
Publications (1)
- DERIVEDBhutiani N, Li Y, Zheng Q, Pandit H, Shi X, Chen Y, Yu Y, Pulliam ZR, Tan M, Martin RCG 2nd. Electrochemotherapy with Irreversible Electroporation and FOLFIRINOX Improves Survival in Murine Models of Pancreatic Adenocarcinoma. Ann Surg Oncol. 2020 Oct;27(11):4348-4359. doi: 10.1245/s10434-020-08782-2. Epub 2020 Jul 17. PMID 32681477