Clinical trial · Interventional
Chemotherapy Followed by Irreversible Electroporation in Patients With Unresectable Locally Advanced Pancreatic Cancer
Chemotherapy Followed by Irreversible Electroporation in Patients With Unresectable Locally Advanced Pancreatic Cancer (CHEMOFIRE-2)
- 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)
This study is a single-arm clinical trial of irreversible electroporation (IRE) for the treatment of unresectable locally advanced pancreatic cancer (LAPC). The aim of the study is to evaluate the efficacy of IRE in this patient group. A statistical analysis of patient survival will be performed, comparing study participants to historical data from the Danish national database of pancreatic cancer patients.
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 |
|---|---|---|---|
| Unresectable Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IRE | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intervention
- interventionNames
- Procedure: IRE
Primary outcomes (1)
- measure
- 2-year survival proportion from 1) diagnosis and 2) IRE
- timeFrame
- 2 years after the last patient is enrolled
Secondary outcomes (11)
- measure
- Median overall survival from 1) diagnosis and 2) IRE
- timeFrame
- 2 years after the last patient is enrolled
- measure
- Progression free survival after IRE
- timeFrame
- 2 years after the last patient is enrolled
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histological or cytologically proven adenocarcinoma/carcinoma of the pancreas. * Largest tumor diameter ≤4 cm in any plane. * \>18 years of age. * Prior treatment with neoadjuvant chemotherapy for at least 2 months * Tumor must be deemed as unresectable at the national pancreatic multidisciplinary team conference after neoadjuvant treatment. * Non-progressive disease according to Response Evaluation Criteria in Solid Tumors v1.1 (RECiST 1.1) after neoadjuvant treatment. * Patients must be able to give informed consent. Exclusion Criteria: * Tumor is inaccessible e.g. due to venous dilation etc. (assessed with preoperative ultrasound). * ASA score \>3 * ECOG performance status \>2 * Pregnancy. * Atrial fibrillation. * Implanted electronic device e.g. cardiac pacemakers or other electrostimulators. * Metal stents or other metallic objects near the ablation zone (unless the stent can be replaced with a plastic stent prior to IRE). * Signs of severe disease of the bone marrow, kidney or liver during time of treatment. Treatment may be postponed if the disease state is reversible. * Severe allergies to anesthetic agent, paralytic agent or any of the equipment used during treatment. * Patient is referred from hospital outside of Denmark
References
Publications (0)
Data not yet available