Clinical trial · Interventional
Trial of IRE in Cholangiocarcinoma
Trial Of IRE in Cholangiocarcinoma (TOnIC): Phase II
NCT03769753CI-TRIAL-00060800completedPhase 2Results postedClinicalTrials.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 purpose of this study is to test any good and bad side effects of surgery using IRE to treat cancer of the bile duct.
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 |
|---|---|---|---|
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IRE Device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- intraoperative use of IRE
- description
- Patients with intraoperatively determined advanced unresectable PHC will be treated with IRE during the same surgical exploration session (N=20). Electrodes will be placed using ultrasound guidance. All electrodes will be placed by hepatopancreatobiliary surgeons with experience using IRE.
- interventionNames
- Device: IRE Device
Primary outcomes (1)
- measure
- Number of Patients Experiencing a Clinically Relevant Complications
- timeFrame
- within 30 days post-IRE
- description
- defined as CTCAE (version 5.0) grade 3 or higher complications
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 years or older * Capable of providing written and oral informed consent in English * Locally advanced disease based on preoperative work-up demonstrating that the tumor is unresectable due to portal vein, hepatic artery, and/or bile duct involvement, insufficient hypertrophy response of the future liver remnant after portal vein embolization, or patients not able to tolerate major liver surgery * Found to be unresectable intraoperatively based on vascular, biliary, or lymph node (N2) involvement upon exploratory laparotomy * Patients will be assessed for chemotherapy prior to treatment with IRE, but given the common problem of recurrent cholangitis, some patients will not be candidates for chemotherapy until after IRE is performed. Exclusion Criteria: * Locally advanced PHC eligible and accepted for liver transplantation evaluation * PHC with \> 5 cm extension along the common hepatic duct or common bile duct on preoperative imaging or intraoperative ultrasound * Metastases to peritoneum, liver or other organs confirmed by percutaneous biopsy, staging laparoscopy or intraoperative frozen section * Lymph node metastases beyond N2 stations, confirmed by intraoperative frozen sections or radiographic diagnosis * 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 are permitted) * Any implanted stimulation device (defined as implantable cardiac device and a pacemaker) * Uncontrolled hypertension (blood pressure must be ≤160/95 mmHg at the time of screening on a stable antihypertensive regimen) * Uncontrolled infections (\> grade 2 NCI-CTC, version 3.0) * Epilepsy * Both narrowing (sclerosis) of the main portal vein and a reduced diameter of either the common hepatic artery, celiac trunk or superior mesenteric artery of \>50%
References
Publications (0)
Data not yet available
No reference posted for this study.