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

Not Applicable

Recruiting

• Conditions: Hepatocellular Carcinoma (HCC)

• Registration Number: NCT06821958
• Lead Sponsor: Charite University, Berlin, Germany

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.

Study Timeline

• Study First Submitted: 2024-12-21
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-11
• Last Update Submitted: 2025-02-11
• Study First Posted: 2025-02-12
• Last Update Posted: 2025-02-12
• Study Start: 2025-03-01
• Primary Completion: 2026-06-15
• Study Completion: 2029-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Objective response rate (ORR)	Every 10-12 weeks until progression or a maximum follow-up of 3 years	Objective response rate

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Charité University Medicine Berlin; 🇩🇪 Berlin, Germany