Trial of IRE in Cholangiocarcinoma

Cholangiocarcinoma Clinical Trial

Official title:

Trial Of IRE in Cholangiocarcinoma (TOnIC): Phase II

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03769753
• Other study ID #: 18-489
• Status: Completed
• Phase: Phase 2
• Start date: December 5, 2018
• Est. completion date: August 16, 2021

Study information

• Verified date: August 2022
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: August 16, 2021
• Est. primary completion date: August 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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%

Related Conditions & MeSH terms

• Cholangiocarcinoma

Intervention

Device:
• IRE Device
For use in ablating soft tissue

Locations

Country	Name	City	State
United States	Memoral Sloan Kettering Basking Ridge (Consent and Follow up)	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Commack (Consent and Follow up)	Commack	New York
United States	Memoral Sloan Kettering Westchester (Consent and Follow Up)	Harrison	New York
United States	Memoral Sloan Kettering Monmouth (Consent and Follow up)	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen (Consent and Follow up)	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Memorial Sloan Kettering Nassau (Consent and Follow-up)	Rockville Centre	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   Memorial Sloan Kettering Cancer Center