Hepatocellular Carcinoma (HCC)
Conditions
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.
Interventions
Radiofrequency electromagnetic field treatment using a carrier frequency of 13.56 MHz
Sponsors
Charite University, Berlin, Germany
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | Every 10-12 weeks until progression or a maximum follow-up of 3 years | Objective response rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life (QoL) | During 4 years of trial conduction | European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 |
| Progression-free survival (PFS) | During 4 years of trial conduction | Progression-free survival |
| Acute and late toxicity | During 4 years of trial conduction | CTCAE version 5 |
| Time to progression (TTP) | During 4 years of trial conduction | Time to progression |
| Duration of response (DOR) | During 4 years of trial conduction | Duration of response |
| Overall survival (OS) | During 4 years of trial conduction | Overall survival |
Countries
Germany
Contacts
Primary ContactPirus Ghadjar, Prof. Dr.
Outcome results
None listed