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Clinical Trials in Germany / NCT06821958
Recruiting Not applicable

Amplitude-modulated Radiofrequency Electromagnetic Field Treatment for Advanced Hepatocellular Carcinoma (Immune-RF)

NCT06821958 · tracked via the Priya Life Science Germany tracker
Phase
Not applicable
Started
2025-03-01
Last updated
2025-02-12

Condition(s) studied

Hepatocellular Carcinoma (HCC)

Investigational drug(s) / intervention(s)

Radiofrequency electromagnetic field treatment

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)

Trial sites (1)

FacilityCityRegionStatus
Charité University Medicine Berlin Berlin Germany Recruiting

More Charite University, Berlin, Germany trials in Germany

Other trials for the same condition

Official registry record

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.

View NCT06821958 on ClinicalTrials.gov ↗ ← All trials in Germany