Radiofrequency electromagnetic field treatment: Radiofrequency electromagnetic field treatment using a carrier frequency of 13.56 MHz
Study summary
Combined double immune checkpoint inhibition and radiofrequency electromagnetic field treatment for patients with advanced hepatocellular carcinoma
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)
Objective response rate (ORR) — Every 10-12 weeks until progression or a maximum follow-up of 3 years Objective response rate
Trial sites (1)
Facility
City
Region
Status
Charité University Medicine Berlin
Berlin
Germany
Recruiting
More Charite University, Berlin, Germany trials in Germany
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.