A phase II study of TAS102 for advanced/recurrent esophageal cancer resistant/intolerable to 5-FU, Platinum compounds, and Taxane - A phase II study of TAS102 for advanced/recurrent esophageal cancer resistant/intolerable to 5-FU, Platinum compounds, and Taxane (ECTAS study)

Kyoto University Hospital0 个研究点目标入组 40 人开始时间: 2015年10月13日最近更新: 2023年10月17日

适应症

试验速览

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•Exclude a patient from this study if any of the following conditions are observed: 1. Has high risk of fistula of the esophagus 2. Has a serious illness or medical condition(s) 3. Has had treatment with any of the following within the specified time frame prior to study drug administration: i. Major surgery within prior 4 weeks. ii. Minor surgery within prior 2 weeks. iii. Extended field radiation within prior 4 weeks or limited field radiation within prior 2 weeks. iv. Any anticancer therapy within prior 3 weeks. v. Any targeted therapies using antibodies including investigational agents received within prior 4 weeks. vi. Any investigational therapies except for investigational agents of v. within prior 4 weeks, excluding therapy with bisphosphonates and anti-RANKL antibodies. 4. Has received TAS-102. 5. Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies (excluding alopecia, dysgeusia, nail damage, and skin pigmentation of any grades, and neurotoxicity of Grade 1-2). 6. Is a pregnant or lactating female. 7. Has a desire for a child 8. Is inappropriate for entry into this study in the judgment of the Investigator.

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