CholangiocarcinomaPhase 2NCT03769753

Trial of IRE in Cholangiocarcinoma

A Phase 2 study testing IRE Device in people with Cholangiocarcinoma, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Cholangiocarcinoma
What is being tested?: IRE Device
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: 7 sitesUnited States
Study dates: 5 Dec 2018to 16 Aug 2021
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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)

Show all 13Show fewer

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%

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

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

Other trials in United States

About this study

Official title: 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.

Conditions: Cholangiocarcinoma
Being tested: IRE Device
Keywords: intraoperative use of IRE, 18-489
Medical subject headings: Cholangiocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IRE DeviceDevice
Also called The NanoKnife IRE device
For use in ablating soft tissue

Study groups in NCT03769753
Study group	Role	What they receive
intraoperative use of IRE	Experimental	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. Receives: Device: IRE Device

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Patients Experiencing a Clinically Relevant Complications
defined as CTCAE (version 5.0) grade 3 or higher complications
Measured: within 30 days post-IRE

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Dec 201816 Aug 2021

First posted7 Dec 2018
Study start5 Dec 2018
Primary completion16 Aug 2021
Study completion16 Aug 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for CholangiocarcinomaStudies of the same condition, open and under way.
More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: This is a prospective, single-center phase I study.
Masking: None (open label)
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03769753
Sponsor's protocol ID: 18-489
Status last verified: Aug 2022
First submitted: 6 Dec 2018
Last updated: 10 Sep 2022
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Active, not recruitingObservational study
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All Cholangiocarcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Trial Of IRE in Cholangiocarcinoma (TOnIC): Phase II
ClinicalTrials.gov ID: NCT03769753
Acronym / sponsor ID: 18-489
Conditions: Cholangiocarcinoma
Keywords: intraoperative use of IRE, 18-489
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 8 participants (actual)
Lead sponsor: Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
Study start: 5 Dec 2018 (actual)
Primary completion: 16 Aug 2021 (actual)
Study completion: 16 Aug 2021 (actual)
First posted: 7 Dec 2018 (actual)
Results: Posted 10 Sep 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: This is a prospective, single-center phase I study.

Arm	Type	Receives
intraoperative use of IRE	Experimental	Device: IRE DevicePatients 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (13 listed)

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:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
IRE DeviceAlso: The NanoKnife IRE deviceFor use in ablating soft tissue	Device	intraoperative use of IRE

Primary outcome

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

Results and safety

Results posted to the registry on 10 Sep 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intraoperative Use of IRE	8	1

Primary outcome: Number of Patients Experiencing a Clinically Relevant Complications

Time frame: within 30 days post-IRE. Count of participants. Unit: Participants

Measure	Intraoperative Use of IRE n = 8
Number of participants with grade 3 or higher complications	1
Number of participants not evaluated for complications	7

Adverse events

Time frame: within 30 days post-IRE. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intraoperative Use of IRE	0 of 8 (0%)	1 of 8 (12.5%)	2 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.

Related trials for Cholangiocarcinoma

Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Active, not recruitingObservational study
Liver Cancer Registry Platform
Hepatocellular Carcinoma (HCC), Cholangiocarcinoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

T. Peter Kingham, MD principal investigator

Memorial Sloan Kettering Cancer Center

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing IRE Device in people with Cholangiocarcinoma, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients Experiencing a Clinically Relevant Complications (time frame: within 30 days post-IRE). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03769753.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2022.