NCT05267080

Registry on Percutaneous Electrochemotherapy

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: Cardiovascular and Interventional Radiological Society of Europe · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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 3 years, with a follow-up period of 1 year. 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 treatment. 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.

Conditions

• Primary Liver Cancer
• Secondary Liver Cancer

Interventions

Type	Name	Description
DEVICE	CLINIPORATOR	The CLINIPORATOR is used to perform percutaneous electrochemotherapy on liver tumours.

Timeline

• Start date: 2023-01-25
• Primary completion: 2026-01-23
• Completion: 2027-01-31
• First posted: 2022-03-04
• Last updated: 2026-02-06

Locations

15 sites across 7 countries: France, Germany, Hungary, Italy, Lithuania, Spain, United Kingdom