Trial Outcomes & Findings for Trial of IRE in Cholangiocarcinoma (NCT NCT03769753)

Last Updated: 2022-09-10

Results Overview

defined as CTCAE (version 5.0) grade 3 or higher complications

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

8 participants

Primary outcome timeframe

within 30 days post-IRE

Results posted on

2022-09-10

Participant milestones
Measure	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. IRE Device: For use in ablating soft tissue
Overall Study STARTED	8
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	7

Reasons for withdrawal
Measure	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. IRE Device: For use in ablating soft tissue
Overall Study Not Treated	6
Overall Study Inevaluable - No Evidence of Disease	1

Trial of IRE in Cholangiocarcinoma

Baseline characteristics by cohort
Measure	Intraoperative Use of IRE n=8 Participants 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. IRE Device: For use in ablating soft tissue
Age, Continuous	72 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	8 Participants n=5 Participants

Timeframe: within 30 days post-IRE

defined as CTCAE (version 5.0) grade 3 or higher complications

Outcome measures
Measure	Intraoperative Use of IRE n=8 Participants 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. IRE Device: For use in ablating soft tissue
Number of Patients Experiencing a Clinically Relevant Complications Number of participants with grade 3 or higher complications	1 Participants
Number of Patients Experiencing a Clinically Relevant Complications Number of participants not evaluated for complications	7 Participants

Serious events: 0 serious events

Other events: 1 other events

Deaths: 2 deaths

Adverse event data not reported

Other adverse events
Measure	Intraoperative Use of IRE n=8 participants at risk 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. IRE Device: For use in ablating soft tissue
Investigations Alkaline phosphatase increased	12.5% 1/8 • within 30 days post-IRE
Blood and lymphatic system disorders Anemia	12.5% 1/8 • within 30 days post-IRE
Investigations Aspartate aminotransferase increased	12.5% 1/8 • within 30 days post-IRE
Investigations Blood bilirubin increased	12.5% 1/8 • within 30 days post-IRE
Investigations Lymphocyte count decreased	12.5% 1/8 • within 30 days post-IRE

Memorial Sloan Kettering Cancer Center

Phone: 212-639-5260