Treatment for advanced liver cancer using radiofrequency electromagnetic fields

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the combined effect of double immune checkpoint inhibition and radiofrequency electromagnetic field treatment in patients with advanced hepatocellular carcinoma (HCC). Conducted at Charité University Medicine Berlin, the trial aims to assess the feasibility of this innovative approach, comparing outcomes with a control group receiving only immune checkpoint inhibitors. The study focuses on patients who are not candidates for curative therapies and have not received prior systemic treatment for HCC. The goal is to gather prospective data on the effectiveness and safety of this combined treatment strategy.

Why it matters

Who can join: the full rules

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

Where it's running

• Charité University Medicine Berlin
  Berlin, Germany Recruiting

Study contacts

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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Biomarker testing to predict treatment response and recurrence in liver cancer

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• Irreversible Electroporation Added to Targeted Therapy and Immunotherapy for Advanced HCC

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  Recruiting Phase 2 Peking Union Medical College Hospital · Beijing, No. 1 Shuaifuyuan, Dongcheng District, Beijing, China · NCT07832006

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.