铂类耐药或难治性卵巢癌是一种高度致命的妇科疾病，治疗选择有限。 Chiauranib是一种新型小分子选择性抑制剂，可有效靶向包括Aurora B、CSF-1R在内的多条通路，抑制细胞周期过程，提高抗肿瘤免疫功能，只要VEGF通路有肿瘤消灭作用。在Ib期单药治疗研究后相继进行，以评估chiauranib联合化疗的疗效。中国复发性卵巢癌患者入组。符合条件的患者接受 Chiauranib 联合最多六个周期的化疗：依托泊苷（CE 组）或每周紫杉醇（CP 组）。在联合治疗后表现出完全或部分缓解或疾病稳定的患者，进入维持阶段接受基奥拉尼单药治疗。主要终点是根据 RECIST v1.1 的无进展生存期 (PFS)。从 2017 年 11 月到 2019 年 3 月，25 名患者参加了 1b 期研究，实现了 3.7 个月的中位 PFS (95% CI 1.8-NE)通过基奥拉尼单一疗法。 2019年7月至2020年12月，共有47名患者入组II期研究。一名 CP 患者没有接受研究药物，三名患者在第一次肿瘤评估前退出。因此，43名患者（CE组：22名患者；CP组：21名患者）被纳入评价。中位 PFS 分别为 5·4 个月 (95% CI 2·8-5·6) 和 5·6 个月 (95% CI 3·4-7·0)。卵巢癌患者的新型多靶点激酶抑制剂。齐奥拉尼与依托泊苷或每周一次的紫杉醇联合给药显着提高了疗效，且不良事件可控。这需要对这种新疗法进行进一步的临床研究。 III 期研究前景广阔且正在进行中。ClinicaTrials.gov 标识符：NCT03901118（II 期）和 NCT03166891（Ib 期）。© 2024。作者。

Platinum-resistant or refractory ovarian cancer is a highly lethal gynecologic disease with limited treatment options. Chiauranib is a novel small-molecule selective inhibitor, which could effectively target multiple pathways including Aurora B and CSF-1R to inhibit cell cycle process and improve anti-tumor immune function, as long as VEGF pathway for tumor extinction.A phase II study was sequentially conducted after a phase Ib monotherapy study to evaluate the efficacy of chiauranib combined with chemotherapy. Chinese patients with recurrent ovarian cancer were enrolled. Eligible patients received chiauranib combined with a maximum of six cycles of chemotherapy: etoposide (CE group) or weekly-paclitaxel (CP group). Patients, who exhibited a complete or partial response, or stable disease following combo treatment, progressed to maintenance phase to receive chiauranib monotherapy. Primary endpoint was progression-free survival (PFS) according to RECIST v1.1.From November 2017 to March 2019, 25 patients were enrolled in a phase 1b study and a median PFS of 3.7 months (95% CI 1.8-NE) was achieved by chiauranib monotherapy. From July 2019 to December 2020, a total of 47 patients were enrolled in the phase II study. One CP patient did not receive the study drugs, and three patients withdrew before the first tumor assessment. Thus, 43 patients (CE group: 22 patients; CP group: 21 patients) were included in the evaluation. The median PFS was 5·4 months (95% CI 2·8-5·6) and 5·6 months (95% CI 3·4-7·0), respectively.This was the first study to evaluate chiauranib, a novel multi-targeted kinase inhibitor in patients with ovarian cancer. The administration of chiauranib along with etoposide or weekly-paclitaxel significantly enhanced the efficacy with manageable adverse events. This warrants further clinical studies on this novel treatment. A phase III study is promising and ongoing.ClinicaTrials.gov identifier: NCT03901118 (phase II) and NCT03166891 (phase Ib).© 2024. The Author(s).