Clinical trial NCT06821958: Amplitude-modulated Radiofrequency Electromagnetic Field Treatment for Advanced Hepatocellular Carcinoma (Immune-RF)
Official title: Amplitude-modulated Radiofrequency Electromagnetic Field Treatment for Advanced Hepatocellular Carcinoma (Immune-RF)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hepatocellular Carcinoma (HCC)
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2025-02-12
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Combined double immune checkpoint inhibition and radiofrequency electromagnetic field treatment for patients with advanced hepatocellular carcinoma

Detailed description: Charité University Medicine Berlin is currently the only German University Hospital with an available capacitive radiofrequency electromagnetic field treatment device. While there is retrospective data available regarding the assumed effectiveness and low toxicity profile of radiofrequency electromagnetic field treatment for various solid tumors including liver cancer, there is no prospective data available on the combined effect of first-line palliative double immune checkpoint inhibition and radiofrequency electromagnetic field treatment for patients with advanced hepatocellular carcinoma. The investigators aim to conduct a feasibility trial and plan to compare the results with data of a prospective trial with a comparable patient population who received double immune checkpoint inhibition alone.

Eligibility criteria: Inclusion Criteria:

* Treatment with combined Anti-PD-L1 and Anti-CTLA-4 antibodies
* Written informed consent prior to any study procedure
* 18 years or older
* Histologically confirmed HCC
* HCC not amenable to curative (including resection or ablation) or locoregional (including TACE) therapies
* No prior systemic therapy for HCC
* Compensated liver function, as defined by a Child-Pugh score ≤ B7
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
* Measurable disease by Response Criteria in Solid Tumors (mRECIST and RECIST v1.1) criteria
* Body weight of \> 30 kg
* Women of childbearing potential with negative pregnancy test and agreement for adequate birth control if conception is possible
* If present HBV and HCV managed according to the local institutional practice

Exclusion criteria:

* Arterioembolic event including a stroke or myocardial infarction within 3 months prior to randomization Severe / unstable angina, or symptomatic congestive heart failure as defined by NYHA III/IV
* Cardiac pacemakers / ICD
* Large metal implants in the treatment area
* Current evidence of coagulopathy or bleeding diathesis
* Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
* Decompensated liver function as defined by Child Pugh ≥ B8
* Patients on a liver transplantation list
* Patients with autoimmune disorders or history of organ transplantation who require immunosuppressive therapy
* Uncontrolled autoimmune or inflammatory disorders
* Patient not able for supine positioning (e.g. due to pain)
* Significantly altered mental status
* Pregnancy and breastfeeding

Primary outcomes:
measure: Objective response rate (ORR)
timeFrame: Every 10-12 weeks until progression or a maximum follow-up of 3 years
Secondary outcomes:
measure: Acute and late toxicity
timeFrame: During 4 years of trial conduction
measure: Quality of life (QoL)
timeFrame: During 4 years of trial conduction
measure: Quality of life (QoL)
timeFrame: During 4 years of trial conduction
measure: Progression-free survival (PFS)
timeFrame: During 4 years of trial conduction
measure: Overall survival (OS)
timeFrame: During 4 years of trial conduction
measure: Time to progression (TTP)
timeFrame: During 4 years of trial conduction
measure: Duration of response (DOR)
timeFrame: During 4 years of trial conduction
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité University Medicine Berlin
Study officials:
References: