[Translation] A multicenter, open, randomized clinical study to evaluate the safety, tolerability, and pharmacokinetic characteristics of melaleuca tablets in the treatment of patients with advanced malignant solid tumors
主要目的:
1) 评价千层纸素片治疗晚期恶性实体瘤患者的安全性和耐受性,确定千层纸素片在晚期恶性实体瘤患者中后续临床试验的推荐剂量;
2) 初步评价千层纸素片在晚期肝细胞癌(HCC)患者中的抗肿瘤活性。
次要目的:
1) 评价千层纸素片在晚期恶性实体瘤患者中的药代动力学(PK)特征;
2) 初步评价千层纸素片在除HCC以外的其他晚期实体瘤患者中的抗肿瘤活性。
[Translation] Main objectives:
1) To evaluate the safety and tolerability of melaleuca tablets in the treatment of patients with advanced malignant solid tumors, and to determine the recommended dose of melaleuca tablets for subsequent clinical trials in patients with advanced malignant solid tumors;
2) To preliminarily evaluate the anti-tumor activity of melaleuca tablets in patients with advanced hepatocellular carcinoma (HCC).
Secondary objectives:
1) To evaluate the pharmacokinetic (PK) characteristics of melaleuca tablets in patients with advanced malignant solid tumors;
2) To preliminarily evaluate the anti-tumor activity of melaleuca tablets in patients with other advanced solid tumors except HCC.