Clinical study of apatinib combined with EGFR-TKI in the treatment of chronic progression after EGFR-TKI treatment in non-small cell lung cancer (ChiCTR1800019185)
Clinical study of apatinib combined with EGFR-TKI in the treatment of chronic progression after EGFR-TKI treatment in non-small cell lung cancer (ChiCTR1800019185)
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阿帕替尼联合EGFR-TKI治疗非小细胞肺癌EGFR-TKI治疗后慢性进展的临床研究（ChiCTR1800019185）
DOI：
10.1111/1759-7714.13303
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发表时间：
2020-01-09
期刊：
影响因子：
2.9
通讯作者：
Chen, Jun
中科院分区：
文献类型：
--
作者：
Li, Xin;Liu, Minghui;Chen, Jun
本临床试验（ChiCTR 1800019185）设计为开放标签、前瞻性、单中心、单臂探索性研究。该研究将招募EGFR-TKI药物一线治疗后进展缓慢的非小细胞肺癌（NSCLC）患者。缓慢进展将通过血清癌胚抗原的存在或影像学评价来证实。主要目的是评估EGFR-TKI联合阿帕替尼250 mg每日一次治疗后的无进展生存期。次要目的是评价客观疗效、疾病控制率、生活质量、总生存期和安全性。从2018年9月至2020年9月，在特定的入组和出院标准下，我们计划入组38例符合条件的患者，直至研究结束。我们希望我们的研究将有助于探索一种新的方法，将抗血管生成的小分子抑制剂与EGFR-TKI结合起来，以克服获得性耐药。
This clinical trial (ChiCTR1800019185) is designed to be an open-label, prospective, single-center, single arm exploratory research study. The study will recruit non-small cell lung cancer patients (NSCLC) with slow progression after first-line treatment with EGFR-TKI drugs. Slow progression will be confirmed by the presence of serum carcinoembryonic antigen or imaging evaluation. The primary aim is to assess progression-free survival after EGFR-TKIs treatment combined with apatinib 250 mg once daily. The secondary objectives are to evaluate objective efficacy, disease control rates, quality of life, overall survival, and safety. From September 2018 to September 2020, under specific entry and discharge standards, we plan to enroll 38 eligible patients until the end of the study. We hope that our study will help to explore a new way of combining the small molecular inhibitors of antiangiogenesis with EGFR-TKIs to overcome acquired drug resistance.