Statistical analysis
death
DISEASE PROGRESSION
The primary endpoint of this study was PFS by the independent central review. Secondary endpoints included OS, response rates, safety profiles, biomarkers, and response rates and PFS with second‐line sorafenib alone after progression in the XP arm. This trial was designed to detect an improvement in PFS when sorafenib was added to the XP (median 7.4 months vs. 5.6 months) with a one‐sided alpha of 0.05 and power of 80%. With consideration of 10% dropout rates, a total of 194 patients were necessary.The efficacy parameters were analyzed in all randomized patients, and the safety was analyzed in the patients who received at least one dose of the study treatment. PFS was defined as the time between randomization and disease progression or death from any cause. OS was calculated as the time from the date of randomization to the date of death from any cause. Patients were censored if they were progression‐free or alive at the last follow‐up. The Chi‐square or Fisher's exact test was used to analyze categorical variables. The probability of survival was estimated using the Kaplan–Meier method and compared using the log‐rank test. Cox proportional hazard model was used to estimate hazard ratios (HRs) and 95% confidence intervals (CI) for the comparison of the efficacy between the two arms and analysis of the prespecified subgroups. All statistical analyses were performed by a dedicated biostatistician (B‐HN) using SAS version 9.1.