Phase III Randomized Study of Sorafenib Plus Doxorubicin Versus Sorafenib in Patients With Advanced Hepatocellular Carcinoma (HCC)

This randomized phase III trial studies sorafenib tosylate and doxorubicin hydrochloride to
see how well they work compared with sorafenib tosylate alone in treating patients with liver
cancer that has spread to nearby tissue or lymph nodes or has spread to other places in the
body. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes
needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy,
such as doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells,
either by killing the cells or by stopping them from dividing. It is not yet known whether
giving sorafenib tosylate together with doxorubicin hydrochloride is more effective than
sorafenib tosylate alone in treating liver cancer.

本随机III期临床试验旨在评估甲苯磺酸索拉非尼（sorafenib tosylate）联合盐酸多柔比星（doxorubicin hydrochloride）对比单用甲苯磺酸索拉非尼，对发生邻近组织/淋巴结转移或远处转移的肝癌患者的治疗效果。甲苯磺酸索拉非尼可通过阻断肿瘤细胞生长所需的部分酶类、抑制肿瘤血供，从而阻滞肿瘤细胞增殖。化疗药物（如盐酸多柔比星）的作用机制各异，可通过杀伤肿瘤细胞或抑制其分裂来阻止肿瘤生长。目前尚不明确，在肝癌治疗中联合应用甲苯磺酸索拉非尼与盐酸多柔比星是否优于单用甲苯磺酸索拉非尼。