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

Launched by CHARITE UNIVERSITY, BERLIN, GERMANY · Feb 11, 2025

Keywords

ClinConnect Summary

This clinical trial, called Immune-RF, is exploring a new treatment for patients with advanced liver cancer, specifically a type known as hepatocellular carcinoma (HCC). The researchers are testing a combination of two immune therapies, which help the body's immune system fight cancer, along with a special type of radiofrequency treatment that uses electromagnetic fields to target the tumor. The goal is to see if this combined approach can improve outcomes for patients whose cancer cannot be treated with standard methods like surgery or localized therapies.

To participate in this trial, patients need to be at least 18 years old and have been diagnosed with HCC that hasn't responded to other treatments. They should also be in good overall health, with stable liver function. The trial is open to both men and women, and participants will need to provide written consent before joining. If eligible, patients can expect to receive the combination treatment and be closely monitored by the medical team throughout the study. It's important to note that patients with certain health conditions, such as severe heart issues or those on a liver transplant list, may not qualify for this trial.

Gender

ALL

Eligibility criteria

• 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