Neoplasms

All Conditions

Head and Neck Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Bleomycin

Anti-Bacterial Agents

Antibiotics, Antitubercular

25 patients treated with electrochemotherapy

Electroporation by a device, Cliniporator, combined with chemotherapy, Bleomycin.

Electrochemotherapy

Electric pulses , duration 100 microseconds, about 400 V given at 5000 Hz.

Cliniporator

Administered intravenously or injected into the tumour before electroporation.

Christina C. Plaschke, MD

Irene Wessel, MD

Julie Gehl, MD

A phase II clinical trial testing electrochemotherapy on mucosal recurrent head and neck cancer. Twenty-five patients will be treated. Primary outcome is tumour response on imaging. Secondary outcomes are response from tissue samples, VAS score, Quality of life evaluation and side effects to treatment.

Electric pulses may be used to transiently permeabilise cell membranes, enabling passage of otherwise non-permeating molecules. This dramatically enhances the cytotoxic effect of certain chemotherapeutic agents, and is termed electrochemotherapy. Electrochemotherapy is now standardly used in the treatment of cutaneous metastases of various cancers in over 100 cancer centers around Europe.

The intention of this trial is to investigate the possible use of electrochemotherapy in recurrent head and neck cancer as a palliative treatment. Surgery and radiotherapy, with the possible addition of chemotherapy, cures a large part of patients with head and neck cancer. However, in the event of recurrence curative options may be exhausted and the patient is referred for palliative chemotherapy.

It is for this patient group, the investigators propose electrochemotherapy in a clinical trial.

The electrochemotherapy is administered as a once-only treatment, with possible retreatment after eight weeks. Under general anesthesia, chemotherapy is administered intravenously, followed by application of electric pulses to the tumour area. Before treatment, the location and spread of the tumour is determined by imaging.

The trial includes evaluation of response by MRI (magnetic resonance imaging) and PET/CT (Positron Emission Tomography - Computed Tomography) scans (base-line, 4 weeks, 8 weeks), tissue samples, as well as adverse events registration and questionnaires on quality of life. The planned study is a phase II clinical study, prospective, observational with up to 25 patients.

Treatments will be performed in collaboration between the Department of Oncology, Copenhagen University Hospital Herlev, which has extensive experience in electrochemotherapy, and the Department of Ear Nose and Throat Surgery at Copenhagen University Hospital Rigshospitalet, that has the surgical expertise and set-up needed.

Electrochemotherapy on Head and Neck Cancer

EORTC scores for head and neck (The European Organisation for Research and Treatment of Cancer)

Copenhagen University Hospital at Herlev

Rigshospitalet, Denmark

Consultant, ph.d., associate professor

Symptoms and General Pathology

Digestive System Diseases

Rare Diseases

Neoplasm Metastasis

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Primary Liver Cancer

Hematinics

Liver Extracts

The CLINIPORATOR is used to perform percutaneous electrochemotherapy on liver tumours.

CLINIPORATOR

Claire Poulet, PhD

Nathalie Kaufmann, MSc

Kathrin Klasic

Lukas Luerken, Dr

Philipp Wiggermann, Prof. Dr.

Attila Kovacs, PD. Dr. med.

The Registry on Percutaneous ElectroChemoTherapy (RESPECT) is a post-market, prospective, non-randomized, observational study aiming at evaluating the effectiveness of percutaneous electrochemotherapy (ECT) for the treatment of liver cancer.

Electrochemotherapy (ECT) is a local tumour ablation technique that uses reversible electroporation to transiently permeabilize the cell membrane in order to increase the cytotoxicity of chemotherapeutic drugs. A major advantage of ECT is that its antitumour efficacy is driven by the chemotherapeutic agent which predominantly targets rapidly-dividing tumour cells, with very little collateral damage on neighbouring structures.

ECT is typically performed using the CLINIPORATOR®, a medical grade pulse generator for clinical electroporation, whose development was funded by the European Commission in an effort to standardize the operating procedures for ECT. The feasibility, safety and efficacy of ECT with the CLINIPORATOR® have been consistently reported for the management of different types of primary and secondary liver cancers: colorectal liver metastasis, hepatocellular carcinoma, portal vein tumour thrombosis from hepatocellular carcinoma, perihilar cholangiocarcinoma and liver metastasis from renal cancer.

While ECT for liver malignancies has been mostly performed intraoperatively, recent studies have successfully used a percutaneous approach. These studies, which were either single-case reports or involved a very limited number of patients (\< 10), have introduced percutaneous ECT as a very promising minimally invasive treatment option for liver cancer, with the obvious benefits of fewer surgical complications, faster recovery and shorter hospitalization. However, results from a larger and more diverse patient population are needed in order to confirm its therapeutic efficacy.

The aim of the RESPECT study is to expand our understanding of percutaneous ECT for primary and secondary liver cancer by 1) substantiating the evidence base for the effectiveness and safety of percutaneous ECT in a large-scale, multi-centric, cross-border sample; and 2) extending the current evidence base regarding percutaneous ECT with appropriately defined follow-up data, as well as information regarding quality of life.

RESPECT is a post-market, prospective, non-randomized, observational study. Patients with any type of liver cancer will be given the possibility to enrol after they are referred to percutaneous ECT by a multidisciplinary tumour board, hence participation to the registry neither affects treatment plan nor influence treatment quality. Patient enrolment will last 2 years, with a follow-up period of maximum 3 years. Data will be collected less than 1 week before treatment (baseline) and at different intervals following treatment (1 day, 2 weeks, 1 month, 3 months, 6 months, 12 months, and every 6 months until the end of the study). Effectiveness of ECT will be primarily assessed by the status of each treated lesion 12 months after ablation. Overall survival, overall local disease-free survival, hepatic disease-free survival, time to untreatable progression by ECT and vacation from systemic cancer therapy will give further insight into the impact of ECT. Safety will be evaluated based on the occurrence and severity of adverse events associated with the treatment. Quality of life and pain will be documented using questionnaires filled by the patients at the first 3 to 4 follow-ups.

Overall, RESPECT intends to provide healthcare professionals and health authorities with information on percutaneous ECT for liver cancer to help decision-making regarding treatment access and treatment modalities and optimize patient care.

Registry on Percutaneous Electrochemotherapy

Based on the tumour status according to mRECIST assessment

Based on the occurrence of adverse events and their severity according to CTCAE v5.0

Based on the Quality of Life questionnaire EORTC QLQ-C30 filled by the patients before ECT treatment and at different time intervals following ECT treatment.

Quality of life data is measured according to three scales: functional scale, symptom scale and global health. On the functional scale, scores range from 1 to 4, with a score of 1 corresponding to no at all and a score of 4 corresponding to very much. On the symptom scale, scores range from 1 to 4, with a score of 1 corresponding to no at all and a score of 4 corresponding to very much.

For global health, the scores range from 1 to 7, with a score of 1 corresponding to either very poor global health or very poor quality of life, and a score of 7 corresponding to either excellent global health or excellent quality of life.

Based on the pain questionnaire filled by the patients before ECT treatment and at different time intervals following ECT treatment.

Severity of pain is graded on a scale from 0 to 10, with 10 corresponding to the most severe pain. Pain frequency is graded from 0 (no pain) to 4 (chronic pain persistent for more than 3 months). Quality of pain is classified into 4 categories: no, somatic, visceral and neuropathic pain.

Survival will be categorized with respect to overall survival, overall local disease-free survival and hepatic disease-free survival

Based on the timeframe until the progressing tumour is not treatable by ECT anymore

Based on the time frame following ECT treatment during which patients do not need systemic cancer therapy

Based on the duration of hospitalization following ECT treatment

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Electrochemotherapy on Head and Neck Cancer	NCT02549742	Head Neck Cance...	Electrochemothe... Cliniporator Bleomycin	18 Years -	Rigshospitalet, Denmark
Registry on Percutaneous Electrochemotherapy	NCT05267080	Primary Liver C... Secondary Liver...	CLINIPORATOR	18 Years -	Cardiovascular and Interventional Radiological Society of Europe
Registry on Percutaneous Electrochemotherapy	NCT05267080	Primary Liver C... Secondary Liver...	CLINIPORATOR	18 Years -	Cardiovascular and Interventional Radiological Society of Europe

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