Statistical Analysis
tumor
ADVERSE EVENT, TUMOR
The sample size was initially intended to be 20 subjects, but due to slow accrual during the COVID-19 pandemic, the study was closed early after 6 subjects were enrolled. All patients who received ≥1 dose of the triple therapy combination were included in the intention-to-treat population and evaluated for safety and antitumor activity. Adverse events were summarized according to frequency, grade, and relationship with each trial drug. Descriptive statistics were tabulated for tumor size. Given the exploratory nature of this study, no adjustments for multiple comparisons were made, and no formal comparisons of dose levels were performed for any endpoints.