Abstract: Objective: To give a panoramic description of the latest research progress on clinical trials and approved products for hepatocellular carcinoma (HCC) in China in 2016-2020 (13^th Five-Year Plan Period).
Methods: Information Disclosure Platform for Drug Clinical Studies and China Food and Drug Administration Query System for Domestic and Imported Drug were searched for registered clinical trials and approved oncology drugs, respectively. The numbers and growth rates of clinical trials and approved products for hepatic carcinoma were analyzed, as well as the relevant variables. The difference between hepatic cancer and other cancers were also compared.
Results: There were 110 trials for HCC registered in China during 13^th Five-Year Plan Period, with an annual growth rate as 52%. Among them, 82 (75%) were initiated by domestic pharmaceutical enterprises. Compared with global enterprises, the proportion of phase I clinical trials and bioequivalence trials sponsored by domestic companies were higher (27% vs. 18%, 33% vs. 0, P =0.0003), while the proportion of therapeutic innovative drugs was lower (54% vs. 100%, P =0.0002). PD-1/PD-L1(19, 54%) and multi-targets of anti-angiogenesis represented by VEGFR (9, 25%) were the main investigated targets of therapeutic innovative targeted drugs. During 2016 to 2020, 6 therapeutic innovative drugs were approved in China.
Conclusions: Clinical trials on anticancer drugs of HCC in China have ushered a booming era during the 13^th Five-Year Plan Period. Local enterprises played more and more critical roles in clinical research and development. PD-1/PD-L1 and multi-targets of anti-angiogenesis are still hotspots for targeted therapy. Exploring clinical oriented anticancer drugs with novel mechanism is crucial direction of future research and development of HCC.

Key words: Hepatocellular carcinoma, Drug, Clinical trial, China