Phase 2
N=25
Treatment of Primary Liver Tumors With Electrochemotherapy (ECT)
Liver Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02291133 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcome: Primary: Number of Participants With Toxicity Related to Electrochemotherapy — 20; 0; 0; 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Electrochemotherapy (Procedure); Cliniporator Vitae® (Device); Bleomycin PHC 15 e. (United States Pharmacopeia - USP) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Masa Bosnjak
- Primary completion
- Sep 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Toxicity Related to Electrochemotherapy |
20; 0; 0; 4 | — |
| SECONDARY Clinical Response Evaluation According to RECIST v1.1 |
19; 4; 1; 0 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Patients with primary liver tumors; hepatocellular carcinoma, intrahepatic cholangiocarcinoma and other primary tumors not larger than 7 cm that are positioned in unresectable liver area, near blood vessels in operable patients.
- 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 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.
- Electrochemotherapy is offered to the patients also when they refuse standard treatments.
- Histologically confirmed primary liver cancer and/or based on radiological imaging laboratory tests confirmed primary liver cancer by multidisciplinary team for liver tumors.
- Age more than 18.
- Life expectancy more than 3 month.
- Performance status Karnofsky ≥ 70 or (World Health Organization) WHO 150 µmol/l).
- Patients with epilepsy.
- Patients with arrhythmias.
- Patients with heart failure or pace maker.
- Pregnancy.
- Patient incapable of understanding the aim of the study or disagree with the entering into the clinical study.
Data sourced from ClinicalTrials.gov (NCT02291133). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.