Clinical trial NCT05267080: Registry on Percutaneous Electrochemotherapy
Official title: Registry on Percutaneous Electrochemotherapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Primary Liver Cancer
Secondary Liver Cancer
Lead sponsor: Cardiovascular and Interventional Radiological Society of Europe
Sponsor class: OTHER
First posted: 2022-03-04
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with primary or secondary liver cancer referred to local ablative treatment by multidisciplinary tumour board and treated with pECT by decision of the interventional radiologist in charge.

Brief 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 (\&lt; 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.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Primary or secondary liver cancer
* Referral to local ablative treatment by multidisciplinary tumour board and decision to treat with pECT by interventional radiologist in charge
* Planned treatment with pECT using the CLINIPORATOR
* Signed informed consent form

Exclusion Criteria:

Pregnancy

Primary outcomes:
measure: Local Tumour Control
timeFrame: 12 months
Secondary outcomes:
measure: Safety (in terms of adverse events related to treatment)
timeFrame: 12 months
measure: Tumour status (size)
timeFrame: End of study (maximum 36 months)
measure: Tumour status (mRECIST)
timeFrame: End of study (maximum 36 months)
measure: Quality of life (EORTC QLQ-C30)
timeFrame: 3 months
measure: Pain assessment
timeFrame: 1 month
measure: Effectiveness (Survival)
timeFrame: End of study (maximum 36 months)
measure: Effectiveness (Time to untreatable progression by ECT)
timeFrame: End of study (maximum 36 months)
measure: Systemic cancer therapy vacation
timeFrame: End of study (maximum 36 months)
measure: Economic aspects
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: MEDICLIN Robert Janker Klinik
city: Braunschweig
country: Germany
facility: Städtisches Klinikum Braunschweig
city: Halle
country: Germany
facility: Universitätsklinikum Halle
city: Leipzig
country: Germany
facility: Helios Park-Klinikum
city: Regensburg
country: Germany
facility: University Hospital Regensburg
city: Milan
country: Italy
facility: Istituto Europeo di Oncologia
city: Rome
country: Italy
facility: Policlinico Universitario A. Gemelli
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santariškių Klinikos
Study officials:
affiliation: Städtisches Klinikum Braunschweig,Braunschweig, Germany
name: Philipp Wiggermann, Prof. Dr.
role: STUDY_CHAIR
affiliation: MediClin Robert Janker Klinik, Bonn, Germany
name: Attila Kovacs, PD. Dr. med.
role: STUDY_CHAIR
References: