一项PT-112联合吉西他滨注射液治疗晚期实体瘤患者的开放性I/II期临床研究
[Translation] An open-label phase I/II clinical study of PT-112 combined with gemcitabine injection in patients with advanced solid tumors
评估PT-112注射液联合吉西他滨注射液治疗晚期实体瘤患者的安全性和耐受性。 估PT-112注射液联合吉西他滨注射液以II期推荐剂量治疗晚期胆道癌患者的抗肿瘤作用。
[Translation] To evaluate the safety and tolerability of PT-112 injection combined with gemcitabine injection in the treatment of patients with advanced solid tumors. To evaluate the antitumor effect of PT-112 injection combined with gemcitabine injection in patients with advanced biliary tract cancer at the recommended dose in phase II.
一项PT-112注射液单药治疗晚期实体瘤患者和晚期肝细胞癌患者的开放性I/II期临床研究
[Translation] An open-label phase I/II clinical study of PT-112 injection monotherapy in patients with advanced solid tumor and advanced hepatocellular carcinoma
剂量递增阶段 主要目的:评估PT-112注射液治疗晚期实体瘤患者的安全性和耐受性。 剂量确认阶段 主要目的:评估PT-112注射液以推荐最高安全剂量治疗晚期实体瘤患者的安全性和耐受性; II期试验阶段 主要目的:评估PT-112注射液以RP2D剂量治疗晚期肝细胞癌的抗肿瘤作用。
[Translation] Dose escalation phase Main objective: To evaluate the safety and tolerability of PT-112 injection in patients with advanced solid tumors. The main purpose of the dose confirmation phase: to evaluate the safety and tolerability of PT-112 injection in the treatment of patients with advanced solid tumors at the highest recommended safe dose; the main purpose of the phase II trial phase: to evaluate the RP2D dose of PT-112 injection in the treatment of advanced hepatocytes Antitumor effect of cancer.
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