The primary goal of this study is to gather efficacy data concerning the progression-free survival rate with electromagnetic fields plus Regorafenib when compared to historical data with Regorafenib alone as a second-line therapy in patients with advanced hepatocellular carcinoma who have received any first line systemic therapy either standard of care Sorafenib or Lenvatinib or any experimental therapy. Patients who have received any treatment that includes either electromagnetic fields or Regorafenib will be excluded.
Primary Objective: To estimate progression-free survival rates. Secondary Objectives * To obtain information concerning the feasibility of administration of the proposed treatment, including patient participation in trials using the proposed treatment. * To evaluate safety and tolerability in this patient population. * To evaluate the effect on levels of alpha-fetoprotein.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Amplitude-modulated electromagnetic fields will be self-administered and given continuously to patients in three courses of 60-minute treatments per day, administered in the morning, at noon and in the evening at the patient's home, with the exception of the first 60-minute treatment, which will be delivered at the research site. Each 4 week treatment period will be considered a cycle of treatment.
Patients will receive 160 mg regorafenib (four 40 mg tablets) orally once daily for the first 3 weeks of each 4-week cycle per approved prescribing information.
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
Progression-Free Survival
Progression-free survival will be estimated along with estimates of 95% confidence intervals for the treatment group. In addition, we will determine the proportion of patients who are progression free after 12 weeks (after 2nd 6-week visit) and compare this to the proportion of patients that were described as progression free in the RESORCE trial using a Simon's two stage design.
Time frame: 12 weeks
Overall Survival
Kaplan Meier curves for patients survival and also estimate the percent of patients who are alive at 6 months and the corresponding 95% Clopper Pearson exact confidence intervals will be calculated.
Time frame: 6 months
Percentage of Participants with Disease Control
Disease control is defined as the percentage of participants alive and have documented response status of complete response, partial response or stable disease according to the modified RECIST (mRECIST) for hepatocellular carcinoma using a 95% Clopper Pearson exact confidence interval. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of longest diameters of target lesions, without evidence of disease progression. Stable Disease (SD): Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease.
Time frame: At 4 months and at 6 months from the date of enrollment
Incidences of Adverse Events
Type, incidence, severity of adverse events graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Adverse events will be described for each CTL type for this study using counts/percent's.
Time frame: Up to 30 days after treatment ends
Comparison of Adverse Events (WFBCCC 55319 to RESORCE historical trial)
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Type, incidence, severity of adverse events graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Adverse events will be compared for each CTL type for the treatment group (WFBCCC 55319 study) and historical control (from the RESORCE trial), using the Fisher's exact test (two-sided) at level 0.05. These comparisons will be made to compare events of grade greater than or equal to 3 between each group.
Time frame: Up to 30 days after treatment ends
Change in Alpha-fetoprotein Levels
Average alpha-fetoprotein level levels will be examined over time, and these changes in Alfa-fetoprotein rates after 6 months will be examined for each Response category (complete response/ partial response/ stable disease/ progressive disease) and tested using a 1-way ANOVA to see if the change in alpha-fetoprotein level differs by response category.
Time frame: 6 months