Jiangsu Allist Pharmaceutical Co., Ltd.

Primary objective: ? To evaluate the efficacy and safety of vometinib mesylate versus placebo by disease-free survival (DFS) Secondary objectives: ? To further evaluate the efficacy of vometinib mesylate versus placebo, including 2-, 3-, and 5-year DFS rates; overall survival (OS); and 5-year survival rate; ? To evaluate the effect of vometinib mesylate versus placebo on health-related quality of life (HRQoL): changes in HRQoL scores measured by SF-36; ? To explore the relationship between pharmacokinetics (PK) and selected endpoints (which may include efficacy, safety, and/or quality of life scores). Describe the PK characteristics of vometinib mesylate and its metabolites, including the concentrations of vometinib mesylate and metabolite AST5902 in plasma; the ratio of metabolites to vometinib mesylate in each PK sample. The PK data of this study will use a population PK approach to analyze the effects of endogenous factors (gender, age, weight, liver and kidney function, etc.) on PK, which may form a combined analysis with data from other studies. ? To assess the safety and tolerability of vometinib mesylate compared with placebo.