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

NCT06821958 | Recruiting

• 1 other identifier: Immune-RF
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hepatocellular Carcinoma (HCC)

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  Objective response rate

  Every 10-12 weeks until progression or a maximum follow-up of 3 years

Secondary Outcomes (7)

• Acute and late toxicity

  During 4 years of trial conduction

• Quality of life (QoL)

  During 4 years of trial conduction

• Quality of life (QoL)

  During 4 years of trial conduction

• Progression-free survival (PFS)

  During 4 years of trial conduction

• Overall survival (OS)

  During 4 years of trial conduction

Study Arms (1)

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

Interventions

Radiofrequency electromagnetic field treatment DEVICE

Radiofrequency electromagnetic field treatment using a carrier frequency of 13.56 MHz

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Treatment with combined Anti-PD-L1 and Anti-CTLA-4 antibodies
• Written informed consent prior to any study procedure
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité University Medicine Berlin

Berlin, 13353, Germany

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Central Study Contacts

Pirus Ghadjar, Prof. Dr.

CONTACT

+49 30 450 527318; pirus.ghadjar@charite.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: December 21, 2024
• First Posted: February 12, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): February 28, 2029
• Last Updated: February 12, 2025

Record last verified: 2025-02

Locations

DE (1)