Adding/removing text The sample size calculation was updated based on a revised statistical design.A correction has been made to the section Methods and analysis, Sample size and statistical analyses, Paragraph 1: "Sample size design: In previous studies, the 6-month PFS rate of the EP/EC regimen was approximately 22%. In this study, we expect to improve the 6-month PFS rate to 50%, with P₀ = 22%, P₁ = 50%, β = 0.2, and a two-sided α = 0.05. Using PASS software and the Two-Stage Phase II clinical trial design, 6 patients will be enrolled in the first stage; if ≥2 patients achieve an objective response (CR/PR), the study will proceed to the second stage with a total of 20 patients. If ≥8 patients in total achieve an objective response, the primary endpoint will be considered met. Assuming a 10% dropout rate, the estimated total sample size is 22 patients, with an expected enrollment period of 3 years."The original version of this article has been updated.
Li et al. (Mon,) studied this question.