OBJECTIVE: To investigate the effect of Xiaoaiping Injection (XAP) on advanced hepatocellular carcinoma (HCC) in patients. METHODS: Sixty-eight patients with advanced HCC were assigned to a control group of 36 and a treatment group of 32.The control group was treated with best supportive treatment (BST) and the treatment group was given XAP plus BST. XAP was administered daily by iv and the treatment course was lasted for 30 days for both groups.The immediate therapeutic efficacy, Karnofsky performance status (KPS) scores, and the changes in immunity indicators (CD3+, CD4+ and CD8+ T cells) were measured and compared before and after treatment. The progression-free survival (PFS) rate and overall survival (OS) rate in the 2 groups were analyzed. RESULTS: The immediate therapeutic efficacy and KPS of the treatment group were better than those in the control group (P0.05). The PFS was 18 weeks in the treatment group and 15 weeks in control group (P