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Trial of IRE in Cholangiocarcinoma

Primary Purpose

Cholangiocarcinoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
IRE Device
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cholangiocarcinoma focused on measuring intraoperative use of IRE, 18-489

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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%

Sites / Locations

  • Memoral Sloan Kettering Basking Ridge (Consent and Follow up)
  • Memoral Sloan Kettering Monmouth (Consent and Follow up)
  • Memorial Sloan Kettering Bergen (Consent and Follow up)
  • Memorial Sloan Kettering Commack (Consent and Follow up)
  • Memoral Sloan Kettering Westchester (Consent and Follow Up)
  • Memorial Sloan Kettering Cancer Center
  • Memorial Sloan Kettering Nassau (Consent and Follow-up)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

intraoperative use of IRE

Arm 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.

Outcomes

Primary Outcome Measures

Number of Patients Experiencing a Clinically Relevant Complications
defined as CTCAE (version 5.0) grade 3 or higher complications

Secondary Outcome Measures

Full Information

First Posted
December 6, 2018
Last Updated
August 16, 2022
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT03769753
Brief Title
Trial of IRE in Cholangiocarcinoma
Official Title
Trial Of IRE in Cholangiocarcinoma (TOnIC): Phase II
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
December 5, 2018 (Actual)
Primary Completion Date
August 16, 2021 (Actual)
Study Completion Date
August 16, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

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

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholangiocarcinoma
Keywords
intraoperative use of IRE, 18-489

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
This is a prospective, single-center phase I study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intraoperative use of IRE
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
IRE Device
Other Intervention Name(s)
The NanoKnife IRE device
Intervention Description
For use in ablating soft tissue
Primary Outcome Measure Information:
Title
Number of Patients Experiencing a Clinically Relevant Complications
Description
defined as CTCAE (version 5.0) grade 3 or higher complications
Time Frame
within 30 days post-IRE

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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%
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
T. Peter Kingham, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memoral Sloan Kettering Basking Ridge (Consent and Follow up)
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Facility Name
Memoral Sloan Kettering Monmouth (Consent and Follow up)
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Facility Name
Memorial Sloan Kettering Bergen (Consent and Follow up)
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Facility Name
Memorial Sloan Kettering Commack (Consent and Follow up)
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Memoral Sloan Kettering Westchester (Consent and Follow Up)
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Memorial Sloan Kettering Nassau (Consent and Follow-up)
City
Rockville Centre
State/Province
New York
ZIP/Postal Code
11570
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mskcc.org/mskcc/html/44.cfm
Description
Memorial Sloan Kettering Cancer Center

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Trial of IRE in Cholangiocarcinoma

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