Wuhan Liyuanheng Pharmaceutical Technology Co., Ltd.

Primary objective: To investigate the safety of ursolic acid nanoliposomes for injection in patients with advanced hepatocellular carcinoma (HCC). Secondary objective: To preliminarily evaluate the clinical efficacy of ursolic acid nanoliposomes for injection in patients with advanced hepatocellular carcinoma (HCC).

To evaluate the safety of ursolic acid nanoliposomes for injection in humans. To obtain the pharmacokinetic parameters of ursolic acid nanoliposomes for injection in humans after continuous administration. To preliminarily observe the anti-tumor effect of ursolic acid nanoliposomes for injection.

On the basis of the completed Phase Ia safety evaluation, we will further investigate the clinical efficacy of ursolic acid nanoliposomes for injection (hereinafter referred to as UAL) in patients with advanced hepatocellular carcinoma, gastric cancer, and colorectal cancer whose disease has progressed after one or more systemic treatments or who have no effective treatment options. We will also conduct preliminary explorations into the usage, dosage, cycle, and course of treatment of the trial drug, in order to provide a basis for the design of further Phase II clinical trials and the determination of dosing regimens.