[Translation] A single-arm, multicenter, open-label phase Ib/IIa clinical study on the efficacy and safety of JJH201601 liposomes for injection in the treatment of patients with advanced pancreatic cancer, biliary tract cancer, and hepatocellular carcinoma
主要目的:评价注射用JJH201601脂质体在晚期胰腺癌、胆道癌和肝细胞癌患者中的有效性。
次要目的:观察注射用JJH201601脂质体在晚期胰腺癌、胆道癌和肝细胞癌患者中的安全性;
评价注射用JJH201601脂质体在晚期胰腺癌、胆道癌和肝细胞癌患者中的有效性;
如数据允许,基于群体药代动力学(PopPK)分析方法,表征JJH201601在晚期胰腺癌、胆道癌和肝细胞癌患者中的PK特征。
[Translation] Primary objective: To evaluate the efficacy of JJH201601 liposomes for injection in patients with advanced pancreatic cancer, biliary tract cancer and hepatocellular carcinoma.
Secondary objective: To observe the safety of JJH201601 liposomes for injection in patients with advanced pancreatic cancer, biliary tract cancer and hepatocellular carcinoma;
To evaluate the efficacy of JJH201601 liposomes for injection in patients with advanced pancreatic cancer, biliary tract cancer and hepatocellular carcinoma;
If data permit, characterize the PK characteristics of JJH201601 in patients with advanced pancreatic cancer, biliary tract cancer and hepatocellular carcinoma based on population pharmacokinetic (PopPK) analysis method.