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

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

Study Overview

• Status: Recruiting
• Conditions: Hepatocellular Carcinoma (HCC)
• Intervention / Treatment: Device: Radiofrequency electromagnetic field treatment

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.

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pirus Ghadjar, Prof. Dr.; Phone Number: +49 30 450 527318; Email: pirus.ghadjar@charite.de

Study Locations

• Germany
  • Berlin, Germany, 13353
    • Recruiting
    • Charité University Medicine Berlin
    • Contact: Yvonne Saewe; Phone Number: +49 30 450 527318; Email: yvonne.saewe@charite.de
    • Contact: Pirus Ghadjar, Prof. Dr.
    • Contact: Raphael Mohr, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; Routine double immune checkpoint inhibition (HIMALAYA phase III trail, STRIDE-arm) combined with radiofrequency electromagnetic field treatment for 60 minutes twice a week	Device: Radiofrequency electromagnetic field treatment; Radiofrequency electromagnetic field treatment using a carrier frequency of 13.56 MHz

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate (ORR)	Objective response rate	Every 10-12 weeks until progression or a maximum follow-up of 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute and late toxicity	CTCAE version 5	During 4 years of trial conduction
Quality of life (QoL)	European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30	During 4 years of trial conduction
Quality of life (QoL)	European Organisation for Research and Treatment of Cancer (EORTC) QLQ-HCC18	During 4 years of trial conduction
Progression-free survival (PFS)	Progression-free survival	During 4 years of trial conduction
Overall survival (OS)	Overall survival	During 4 years of trial conduction
Time to progression (TTP)	Time to progression	During 4 years of trial conduction
Duration of response (DOR)	Duration of response	During 4 years of trial conduction

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): February 28, 2029

Study Registration Dates

• First Submitted: December 21, 2024
• First Submitted That Met QC Criteria: February 11, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 11, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular
• Other Study ID Numbers: Immune-RF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No