Efficacy and safety analyses
Tumors, toxicities, tumor, death
TUMOR, LIVER, DISEASE, TUMORS, SECONDARY
Liver and renal function tests, routine blood examination, alpha-fetoprotein (AFP) levels, electrocardiogram (ECG), chest X-ray, and abdominal ultrasound were measured at baseline, before each chemotherapy cycle, and then once every 2 ± 1 months during the follow-up phase. Objective responses were assessed at least 2 weeks after the last chemotherapy cycle. For tumor evaluation, CT or MRI was carried out according to the Revised Response Evaluation Criteria in Solid Tumors (mRECIST)Overall survival (OS) was the primary endpoint, which was defined as the duration between randomization and the time of death from any cause. PFS, ORR, and disease control rate (DCR) are the secondary endpoints.Study drug toxicities were assessed once every 2 weeks during the treatment phase and were evaluated via vital signs, physical/neurological examination, ECG, Echo, and clinical laboratory tests. All AEs were assessed based on the NCI CTCAE (Version 4.0)