Therapeutic options for patients with advanced hepatocellular carcinoma (HCC) are limited. There is emerging evidence that the growth of cancer cells may be altered by very low levels of electromagnetic fields modulated at specific frequencies. A single-group, open-label, phase I/II study was performed to assess the safety and effectiveness of the intrabuccal administration of very low levels of electromagnetic fields amplitude-modulated at HCC-specific frequencies in 41 patients with advanced hepatocellular carcinoma and limited therapeutic options. Three daily 60 minute outpatient treatments were administered until disease progression or death. Imaging studies were performed every 8 weeks. The primary efficacy end point was progression-free survival (PFS) ≥ 6 months. Secondary efficacy end points were progression-free survival and overall survival (OS). Treatment was well tolerated and there were no NCI grade 2, 3 or 4 toxicities. Fourteen patients (34.1%) had stable disease for more than 6 months. Median progression-free survival was 4.4 months (95% CI 2.1-5.3) and median overall survival was 6.7 months (95% CI 3.0-10.2). There were three partial and one near complete responses.
The scientific and technical impact of the study can be summarized as: