Trial of IRE in Cholangiocarcinoma

Trial Of IRE in Cholangiocarcinoma (TOnIC): Phase II

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.

Study Overview

• Status: Completed
• Conditions: Cholangiocarcinoma
• Intervention / Treatment: Device: IRE Device

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Memoral Sloan Kettering Basking Ridge (Consent and Follow up)
    • Middletown, New Jersey, United States, 07748
      • Memoral Sloan Kettering Monmouth (Consent and Follow up)
    • Montvale, New Jersey, United States, 07645
      • Memorial Sloan Kettering Bergen (Consent and Follow up)
  • New York
    • Commack, New York, United States, 11725
      • Memorial Sloan Kettering Commack (Consent and Follow up)
    • Harrison, New York, United States, 10604
      • Memoral Sloan Kettering Westchester (Consent and Follow Up)
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
    • Rockville Centre, New York, United States, 11570
      • Memorial Sloan Kettering Nassau (Consent and Follow-up)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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%

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intraoperative use of IRE; 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.	Device: IRE Device; For use in ablating soft tissue; Other Names: The NanoKnife IRE device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients Experiencing a Clinically Relevant Complications	defined as CTCAE (version 5.0) grade 3 or higher complications	within 30 days post-IRE

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2018
• Primary Completion (Actual): August 16, 2021
• Study Completion (Actual): August 16, 2021

Study Registration Dates

• First Submitted: December 6, 2018
• First Submitted That Met QC Criteria: December 6, 2018
• First Posted (Actual): December 7, 2018

Study Record Updates

• Last Update Posted (Actual): September 10, 2022
• Last Update Submitted That Met QC Criteria: August 16, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: intraoperative use of IRE; 18-489
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Cholangiocarcinoma
• Other Study ID Numbers: 18-489

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No