[Translation] A non-randomized, open, single-arm, centralized competitive enrollment, multicenter Phase Ib/IIa clinical trial to evaluate the efficacy, pharmacokinetic/pharmacodynamic characteristics, and safety of DX1002 tablets in patients with advanced hepatocellular carcinoma/gastric cancer
1.主要目的:评价DX1002在中国晚期肝细胞癌/胃癌病人中的有效性,为下一步临床研究提供参考。
2.次要目的:进一步评价DX1002给药后在中国晚期肝细胞癌/胃癌病人中的药代/药效动力学特征。评价用药前后受试者生活质量的变化情况。进一步评价DX1002给药后在中国晚期肝细胞癌/胃癌病人中的安全性和耐受性。
3.探索性目的:(仅探索阶段)观察用药前后肿瘤靶病灶内部坏死情况。观察用药前后肿瘤靶病灶内部血供变化情况。
[Translation] 1. Primary purpose: To evaluate the effectiveness of DX1002 in Chinese patients with advanced hepatocellular carcinoma/gastric cancer, and provide reference for the next clinical study.
2. Secondary purpose: To further evaluate the pharmacokinetic/pharmacodynamic characteristics of DX1002 in Chinese patients with advanced hepatocellular carcinoma/gastric cancer after administration. To evaluate the changes in the quality of life of the subjects before and after administration. To further evaluate the safety and tolerability of DX1002 in Chinese patients with advanced hepatocellular carcinoma/gastric cancer after administration.
3. Exploratory purpose: (Exploratory stage only) To observe the internal necrosis of the tumor target lesions before and after administration. To observe the changes in the blood supply of the tumor target lesions before and after administration.