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Abstract: Primary liver cancer is the fourth leading causes of cancer-related death worldwide
and the second in China. Based on the national conditions of China as a large country of
hepatitis B, new liver cancer in China accounted for 46.6% of global liver cancer in 2018.
Due to the special tumor biological behavior of primary liver cancer, curative treatments
such as hepatic resection, liver transplantation and radiofrequency ablation are indicated in
only 20%～30% of patients. Most patients are diagnosed at advanced stages when curative
therapies are no longer available. Therefore, systematic treatment is particularly important for
patients with advanced liver cancer. Sorafenib had remained as the only United States Food
and Drug Administration (US-FDA) approved systemic therapeutic agent since its approval
in 2007, however, as the total effective rate was only 2.3%, and accompanied by serious drug
side effects, sorafenib has been greatly restricted in advanced liver cancer. The systematic
treatment of advanced liver cancer has undergone a historic change. Based on the results of
the phase Ⅲ clinical trial of lenvatinib, lenvatinib is a frst-line drug newly approved by the
food and Drug Administration (FDA) for the treatment of advanced liver cancer. In 2017,
the subgroup analysis of Chinese patients in phase Ⅲ clinical trial published by the Chinese
society of Clinical Oncology (CSCO) showed that lenvatinib had more obvious benefts. In
September 2018, it was confrmed that lenvatinib could be approved in China. Based on the
experience of using lenvatinib in China in the past 5 years, this article reviewed the clinical
trials and combination treatments of lenvatinib in primary liver cancer.
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