Trial Outcomes & Findings for Treatment of Primary Liver Tumors With Electrochemotherapy (ECT) (NCT NCT02291133)
NCT ID: NCT02291133
Last Updated: 2021-07-23
Results Overview
Biochemistry, blood test and/or US
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
25 participants
Primary outcome timeframe
After operation on day 7
Results posted on
2021-07-23
Participant Flow
Participant milestones
| Measure |
Electrochemotherapy Treatment
Electrochemotherapy: Exploration, anesthesia, adhesiolysis, mobilization of liver, intra-operative US or CT, bleomycin administration, electroporation
Cliniporator Vitae®: Positioning of electrodes, 8-28 min after administration of bleomycin application of electric pulses (8 pulses, duration 100 microseconds, frequency 8 Hz with amplitude adequate to cover the whole treated lesion with electric field necessary for reversible plasma membrane permeabilization), removal of electrodes.
The maximum duration of procedure is 90 minutes, after liver mobilization.
Bleomycin PHC 15 e. (United States Pharmacopeia - USP): Intravenous in bolus administration of bleomycin (15 mg/m2)
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
24
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment of Primary Liver Tumors With Electrochemotherapy (ECT)
Baseline characteristics by cohort
| Measure |
Electrochemotherapy Treatment
n=24 Participants
Electrochemotherapy: Exploration, anesthesia, adhesiolysis, mobilization of liver, intra-operative US or CT, bleomycin administration, electroporation
Cliniporator Vitae®: Positioning of electrodes, 8-28 min after administration of bleomycin application of electric pulses (8 pulses, duration 100 microseconds, frequency 8 Hz with amplitude adequate to cover the whole treated lesion with electric field necessary for reversible plasma membrane permeabilization), removal of electrodes.
The maximum duration of procedure is 90 minutes, after liver mobilization.
Bleomycin PHC 15 e. (United States Pharmacopeia - USP): Intravenous in bolus administration of bleomycin (15 mg/m2)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=99 Participants
|
|
Age, Continuous
|
65.6 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: After operation on day 7Biochemistry, blood test and/or US
Outcome measures
| Measure |
Electrochemotherapy Treatment
n=24 Participants
Electrochemotherapy: Exploration, anesthesia, adhesiolysis, mobilization of liver, intra-operative US or CT, bleomycin administration, electroporation
Cliniporator Vitae®: Positioning of electrodes, 8-28 min after administration of bleomycin application of electric pulses (8 pulses, duration 100 microseconds, frequency 8 Hz with amplitude adequate to cover the whole treated lesion with electric field necessary for reversible plasma membrane permeabilization), removal of electrodes.
The maximum duration of procedure is 90 minutes, after liver mobilization.
Bleomycin PHC 15 e. (United States Pharmacopeia - USP): Intravenous in bolus administration of bleomycin (15 mg/m2)
|
|---|---|
|
Number of Participants With Toxicity Related to Electrochemotherapy
No adverse events
|
20 Participants
|
|
Number of Participants With Toxicity Related to Electrochemotherapy
ECT-related adverse events
|
0 Participants
|
|
Number of Participants With Toxicity Related to Electrochemotherapy
Non-ECT-related within 24 h
|
0 Participants
|
|
Number of Participants With Toxicity Related to Electrochemotherapy
Non-ECT-related after 24 h
|
4 Participants
|
SECONDARY outcome
Timeframe: After operation on days 1, 7, 30, 60, 90, 120Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI/CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Outcome measures
| Measure |
Electrochemotherapy Treatment
n=24 Participants
Electrochemotherapy: Exploration, anesthesia, adhesiolysis, mobilization of liver, intra-operative US or CT, bleomycin administration, electroporation
Cliniporator Vitae®: Positioning of electrodes, 8-28 min after administration of bleomycin application of electric pulses (8 pulses, duration 100 microseconds, frequency 8 Hz with amplitude adequate to cover the whole treated lesion with electric field necessary for reversible plasma membrane permeabilization), removal of electrodes.
The maximum duration of procedure is 90 minutes, after liver mobilization.
Bleomycin PHC 15 e. (United States Pharmacopeia - USP): Intravenous in bolus administration of bleomycin (15 mg/m2)
|
|---|---|
|
Clinical Response Evaluation According to RECIST v1.1
stable disease (SD)
|
1 Participants
|
|
Clinical Response Evaluation According to RECIST v1.1
progressive disease (PD)
|
0 Participants
|
|
Clinical Response Evaluation According to RECIST v1.1
complete response (CR)
|
19 Participants
|
|
Clinical Response Evaluation According to RECIST v1.1
partial response (PR)
|
4 Participants
|
Adverse Events
Electrochemotherapy Treatment
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Electrochemotherapy Treatment
n=24 participants at risk
Electrochemotherapy: Exploration, anesthesia, adhesiolysis, mobilization of liver, intra-operative US or CT, bleomycin administration, electroporation
Cliniporator Vitae®: Positioning of electrodes, 8-28 min after administration of bleomycin application of electric pulses (8 pulses, duration 100 microseconds, frequency 8 Hz with amplitude adequate to cover the whole treated lesion with electric field necessary for reversible plasma membrane permeabilization), removal of electrodes.
The maximum duration of procedure is 90 minutes, after liver mobilization.
Bleomycin PHC 15 e. (United States Pharmacopeia - USP): Intravenous in bolus administration of bleomycin (15 mg/m2)
|
|---|---|
|
General disorders
Clavien-Dindo Classification, Grade I
|
45.8%
11/24 • Number of events 11 • 7, 30, 60, 90, 120 days
|
|
Hepatobiliary disorders
Clavien-Dindo Classification, Grade II
|
8.3%
2/24 • Number of events 2 • 7, 30, 60, 90, 120 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place