[Translation] Clinical study on the tolerability, safety and pharmacokinetics of umomostat bisulfate capsule combined with gemcitabine hydrochloride in the treatment of patients with locally advanced/metastatic pancreatic cancer
主要目的 评价硫酸氢乌莫司他胶囊(LH011)联合盐酸吉西他滨(GEM)治疗局部晚期/转移性胰腺癌患者的耐受性、安全性,并确定LH011联合GEM的MTD,为下一临床试验提供推荐剂量。 次要目的 评价LH011及代谢产物的药代动力学特征; 评价LH011联合GEM对局部晚期/转移性胰腺癌的疗效; 评估LH011对肿瘤标志物(CA19-9)和uPA相关标志物(如D-二聚体)的影响。
[Translation] Primary objective To evaluate the tolerability and safety of umomostat bisulfate capsules (LH011) combined with gemcitabine hydrochloride (GEM) in the treatment of patients with locally advanced/metastatic pancreatic cancer, and to determine the MTD of LH011 combined with GEM, so as to provide a recommended dose for the next clinical trial. Secondary objectives To evaluate the pharmacokinetic characteristics of LH011 and its metabolites; To evaluate the efficacy of LH011 combined with GEM in the treatment of locally advanced/metastatic pancreatic cancer; To evaluate the effect of LH011 on tumor markers (CA19-9) and uPA-related markers (such as D-dimer).