Trial Outcomes & Findings for Treatment of Liver Metastases With Electrochemotherapy (ECTJ) Phase II (NCT NCT02352259)
NCT ID: NCT02352259
Last Updated: 2021-03-24
Results Overview
Recording of adverse events according to CTCAE criteria
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
23 participants
Primary outcome timeframe
After operation on day 7
Results posted on
2021-03-24
Participant Flow
Participant milestones
| Measure |
Electrochemotherapy
All patients were administered with intravenous bolus of bleomycin (15,000 IU/m2, Bleomycin medac, Medac, Hamburg, Germany), after intraoperative ultrasound confirmed the correct electrode placement. Eight minutes after bleomycin injection, electric pulses were delivered by Cliniporator®VITAE (IGEA SpA, Carpi, Italy).
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|---|---|
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Overall Study
STARTED
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23
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Overall Study
COMPLETED
|
23
|
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment of Liver Metastases With Electrochemotherapy (ECTJ) Phase II
Baseline characteristics by cohort
| Measure |
Electrochemotherapy
n=23 Participants
All patients were administered with intravenous bolus of bleomycin (15,000 IU/m2, Bleomycin medac, Medac, Hamburg, Germany), after intraoperative ultrasound confirmed the correct electrode placement. Eight minutes after bleomycin injection, electric pulses were delivered by Cliniporator®VITAE (IGEA SpA, Carpi, Italy).
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=99 Participants
|
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Age, Categorical
Between 18 and 65 years
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9 Participants
n=99 Participants
|
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Age, Categorical
>=65 years
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14 Participants
n=99 Participants
|
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Sex: Female, Male
Female
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6 Participants
n=99 Participants
|
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Sex: Female, Male
Male
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17 Participants
n=99 Participants
|
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=99 Participants
|
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Race (NIH/OMB)
Asian
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0 Participants
n=99 Participants
|
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=99 Participants
|
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Race (NIH/OMB)
Black or African American
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0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=99 Participants
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Region of Enrollment
Slovenia
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23 participants
n=99 Participants
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CRC liver metastases
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23 metastases
n=99 Participants
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PRIMARY outcome
Timeframe: After operation on day 7Recording of adverse events according to CTCAE criteria
Outcome measures
| Measure |
Electrochemotherapy
n=23 Participants
All patients were administered with intravenous bolus of bleomycin (15,000 IU/m2, Bleomycin medac, Medac, Hamburg, Germany), after intraoperative ultrasound confirmed the correct electrode placement. Eight minutes after bleomycin injection, electric pulses were delivered by Cliniporator®VITAE (IGEA SpA, Carpi, Italy).
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|---|---|
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Evaluation of Safety Related to Electrochemotherapy
No adverse events
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20 Participants
|
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Evaluation of Safety Related to Electrochemotherapy
ECT nonrelated mild adverse avents
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3 Participants
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Evaluation of Safety Related to Electrochemotherapy
ECT related mild adverse avents
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0 Participants
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Evaluation of Safety Related to Electrochemotherapy
Adverse avents
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0 Participants
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SECONDARY outcome
Timeframe: After operation on the days 30, 60, 90 and 120Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) 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
n=23 Participants
All patients were administered with intravenous bolus of bleomycin (15,000 IU/m2, Bleomycin medac, Medac, Hamburg, Germany), after intraoperative ultrasound confirmed the correct electrode placement. Eight minutes after bleomycin injection, electric pulses were delivered by Cliniporator®VITAE (IGEA SpA, Carpi, Italy).
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|---|---|
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Response to Treatment (Determined by Modified RECIST Criteria).
complete response (CR)
|
10 Participants
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Response to Treatment (Determined by Modified RECIST Criteria).
partial response (PR)
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4 Participants
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Response to Treatment (Determined by Modified RECIST Criteria).
progressive disease (PD)
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9 Participants
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Adverse Events
Electrochemotherapy
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Electrochemotherapy
n=23 participants at risk
All patients were administered with intravenous bolus of bleomycin (15,000 IU/m2, Bleomycin medac, Medac, Hamburg, Germany), after intraoperative ultrasound confirmed the correct electrode placement. Eight minutes after bleomycin injection, electric pulses were delivered by Cliniporator®VITAE (IGEA SpA, Carpi, Italy).
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|---|---|
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Infections and infestations
SIRS
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4.3%
1/23 • 7, 30, 60, 90, 120 days
adverse events observed in 3 out of 23 patients, no serious adverse events
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Cardiac disorders
arrhythmia
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4.3%
1/23 • 7, 30, 60, 90, 120 days
adverse events observed in 3 out of 23 patients, no serious adverse events
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Hepatobiliary disorders
abscess
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4.3%
1/23 • 7, 30, 60, 90, 120 days
adverse events observed in 3 out of 23 patients, no serious adverse events
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place