A Phase 1/2 interventional study of Electrochemotherapy and Cliniporator Vitae® in Liver Cancer, sponsored by Masa Bosnjak. Completed at 1 site in Slovenia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-23.
Sponsored by Masa Bosnjak · Phase 1/2, Interventional, and Treatment
The aim of the study is to evaluate toxicity and effectiveness of electrochemotherapy with bleomycin in treatment of primary liver tumors in clinical study phase I and II.
The study will include 10 patients in phase I clinical study and additional 15 patients in phase II clinical study (or in the extension of the clinical study), which will fulfill inclusion criteria.
Treatment effectiveness will be evaluated by DCE-US or CT perfusion, to detect early events in tumor perfusion after ECT compared to tumor perfusion before ECT. Long term effectiveness of the treatment will be evaluated by modified RECIST criteria, which will take into account difference in size and density, determined from images obtained by CT perfusion of the treated tumor nodules before and after ECT. Tumor volume will be calculated by following formula , where a will be shorter and b longer tumor diameter.
The secondary objectives of the trial are to quantify the impact of the treatment on the patient's quality of life, tolerance to the therapy and suitability for larger study to be conducted.
The study will be conducted on patients with primary liver tumors. 10 patients will be included in phase I clinical study and additional 15 patients in phase II clinical study (or in the extension of the clinical study).
Depending on the position of tumors, appropriate electrodes will be selected; hexagonal needle electrodes with fixed geometry for tumors not larger than 3 cm in diameter, where lower edge of the tumor is located up to 3 cm below the liver capsule or longer single needle electrodes. Individual electrodes, positioned according to the prepared treatment plan will be used for tumors up to 7 cm in diameter, or located near vena cava or large hepatic or portal veins.
Electrochemotherapy will be performed within 8-28 min after intravenous in bolus administration of bleomycin (15 mg/m2).
Triggering of electric pulses will be synchronized with ECG signals, through the ECG triggering device AccuSync to avoid delivery of pulses in vulnerable period of the heart.
All patients will be treated after the procedure has been thoroughly described to them, and have signed informed consent.
1,391 studies on the registry are indexed under Liver Neoplasms; 345 are open to participants now.
This study's enrollment of 25 is below the median of 47 across 968 interventional studies indexed under Liver Neoplasms.
Browse Liver Neoplasms studies →This is the only study on the registry with Masa Bosnjak as lead sponsor.
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Patients with the progression of the disease (confirmed by radiological imaging) after treatment with TACE, RFA or percutaneous alcohol ablation, which are not suitable for potentially curative treatment, but with relatively good "performance status" and Child-Pugh score \< 8.
Patients from group 1. and 2. are patients, in whom standard treatment procedures are not eligible, so ECT will be the only therapeutic option. In patients with multiple liver tumors, unresectable tumors which are also unsuitable for RAF will be treated by ECT, whereas other tumors will be resected or treated by RAF.
Patients with tumors> 4 cm in diameter, in difficult to reach locations, and patients unsuitable for treatment with other treatment options.
Patients from group 3. and 4. are patients, potentially curable with standard treatment. Electrochemotherapy in these patients will not affect the standard of care of these patients, recommended in guidelines for HCC.
Exclusion Criteria:
Procedure: Electrochemotherapy · Device: Cliniporator Vitae® · Drug: Bleomycin PHC 15 e. (United States Pharmacopeia - USP)
Exploration, anesthesia, adhesiolysis, mobilization of liver, intra-operative US or CT, bleomycin administration, electroporation
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.
Intravenous in bolus administration of bleomycin (15 mg/m2)
Number of Participants With Toxicity Related to Electrochemotherapy
Biochemistry, blood test and/or US
Time frame: After operation on day 7
Clinical Response Evaluation According to RECIST v1.1
Response 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
Time frame: After operation on days 1, 7, 30, 60, 90, 120
| Milestone | Electrochemotherapy Treatment |
|---|---|
| Started | 25 |
| Completed | 24 |
| Not completed | 1 |
Biochemistry, blood test and/or US
| Participants | Electrochemotherapy Treatment |
|---|---|
| No adverse events | 20 |
| ECT-related adverse events | 0 |
| Non-ECT-related within 24 h | 0 |
| Non-ECT-related after 24 h | 4 |
Response 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
| Participants | Electrochemotherapy Treatment |
|---|---|
| complete response (CR) | 19 |
| partial response (PR) | 4 |
| stable disease (SD) | 1 |
| progressive disease (PD) | 0 |
Collected over 7, 30, 60, 90, 120 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Electrochemotherapy Treatment | 0/24 (0%) | 0/24 (0%) | 15/24 (62.5%) |
| Event | Electrochemotherapy Treatment |
|---|---|
| Clavien-Dindo Classification, Grade IGeneral disorders | 11/24 |
| Clavien-Dindo Classification, Grade IIHepatobiliary disorders | 2/24 |
| Age, Categorical(Participants) | Electrochemotherapy Treatment |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 9 |
| >=65 years | 15 |
| Age, Continuous(years) | Electrochemotherapy Treatment |
|---|---|
| Median | 65.6 (52 to 78) |
| Sex: Female, Male(Participants) | Electrochemotherapy Treatment |
|---|---|
| Female | 7 |
| Male | 17 |
| Race (NIH/OMB)(Participants) | Electrochemotherapy Treatment |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 24 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
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