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MechanismArginase replacements [+1] |
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Drug Highest PhaseNDA/BLA |
First Approval Ctry. / Loc.- |
First Approval Date- |
ADI-PEG20 联合FOLFOX 治疗晚期胃肠道恶性肿瘤以肝细胞癌受试者为主的 第1-2期临床研究
[Translation] A Phase 1-2 clinical study of ADI-PEG20 combined with FOLFOX in the treatment of advanced gastrointestinal malignancies, mainly hepatocellular carcinoma subjects
主要目标是由设盲独立中心评估(BICR)按照RECIST 1.1标准评估确定客观缓解率(ORR),次要目标是确定无进展生存期(PFS),总生存期(OS),缓解持续时间(DoR),疾病控制率(DCR),药效学,药代动力学,免疫原性及AFP变化。
[Translation] The primary objective was to determine the objective response rate (ORR) by blinded independent central review (BICR) according to RECIST 1.1 criteria, and the secondary objectives were to determine progression-free survival (PFS), overall survival (OS), duration of response (DoR), disease control rate (DCR), pharmacodynamics, pharmacokinetics, immunogenicity and changes in AFP.
100 Clinical Results associated with Dirui Pharmaceutical (Chengdu) Co., Ltd.
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100 Translational Medicine associated with Dirui Pharmaceutical (Chengdu) Co., Ltd.