Combined double immune checkpoint inhibition and radiofrequency electromagnetic field treatment for patients with advanced hepatocellular carcinoma
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Radiofrequency electromagnetic field treatment using a carrier frequency of 13.56 MHz
Charité University Medicine Berlin
Berlin, Germany
RECRUITINGObjective response rate (ORR)
Objective response rate
Time frame: Every 10-12 weeks until progression or a maximum follow-up of 3 years
Acute and late toxicity
CTCAE version 5
Time frame: During 4 years of trial conduction
Quality of life (QoL)
European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30
Time frame: During 4 years of trial conduction
Quality of life (QoL)
European Organisation for Research and Treatment of Cancer (EORTC) QLQ-HCC18
Time frame: During 4 years of trial conduction
Progression-free survival (PFS)
Progression-free survival
Time frame: During 4 years of trial conduction
Overall survival (OS)
Overall survival
Time frame: During 4 years of trial conduction
Time to progression (TTP)
Time to progression
Time frame: During 4 years of trial conduction
Duration of response (DOR)
Duration of response
Time frame: During 4 years of trial conduction
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