ICON9：一项国际性 III 期随机研究，旨在评估奥拉帕利联合 cediranib 或奥拉帕利单药维持治疗在铂类化疗有反应的复发性铂敏感卵巢癌患者中的疗效。
ICON 9-an international phase III randomized study to evaluate the efficacy of maintenance therapy with olaparib and cediranib or olaparib alone in patients with relapsed platinum-sensitive ovarian cancer following a response to platinum-based chemotherapy.
机构信息
University College CRUK and UCL Cancer Trials Centre, UCL Cancer Institute, London, UK
University College CRUK and UCL Cancer Trials Centre, UCL Cancer Institute, London, UK.
出版信息
Int J Gynecol Cancer. 2021 Jan;31(1):134-138. doi: 10.1136/ijgc-2020-002073. Epub 2020 Oct 23.
BACKGROUND
Two novel biological agents-cediranib targeting angiogenesis, and olaparib targeting DNA repair processes-have individually led to an improvement in ovarian cancer control. The aim of ICON9 is to investigate the combination of cediranib and olaparib maintenance in recurrent ovarian cancer following platinum-based therapy.
PRIMARY OBJECTIVE
To assess the efficacy of maintenance treatment with olaparib in combination with cediranib compared with olaparib alone following a response to platinum-based chemotherapy in women with platinum-sensitive ovarian, fallopian tube or peritoneal cancer during first relapse.
STUDY HYPOTHESIS
Maintenance therapy with cediranib and olaparib in combination is associated with improved patient outcomes compared with olaparib alone.
TRIAL DESIGN
International phase III randomized controlled trial. Following a response to platinum-based chemotherapy patients are randomized 1:1 to either oral olaparib and cediranib (intervention arm) or oral olaparib alone (control arm).
MAJOR INCLUSION CRITERIA
Patients with a known diagnosis of high grade serous or endometrioid carcinoma of the ovary, fallopian tube or peritoneum, progressing more than 6 months after first-line platinum-based chemotherapy, who have responded to second-line platinum-based chemotherapy.
PRIMARY ENDPOINTS
Progression-free and overall survival. Co-primary endpoints to be assessed using a fixed-sequence gatekeeping approach: (1) progression-free survival, all patients; (2) progression-free survival, BRCA wild type; (3) overall survival, all patients; (4) overall survival, BRCA wild type.
SAMPLE SIZE
618 patients will be recruited.
ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS
Accrual is expected to be completed in 2024 with presentation of results in 2025.
TRIAL REGISTRATION
ClinicalTrials.gov: NCT03278717.
背景
两种新型生物制剂——靶向血管生成的西地尼布和靶向 DNA 修复过程的奥拉帕利——各自都改善了卵巢癌的控制效果。ICON9 的目的是研究在铂类治疗后复发的卵巢癌中，西地尼布联合奥拉帕利维持治疗的效果。
主要目标
评估在铂类敏感的卵巢、输卵管或腹膜癌患者首次复发时，在对铂类化疗有反应后，用奥拉帕利联合西地尼布维持治疗与单独用奥拉帕利相比，对患者的疗效。
研究假设
西地尼布联合奥拉帕利维持治疗与单独用奥拉帕利相比，可改善患者的预后。
试验设计
国际 III 期随机对照试验。在对铂类化疗有反应后，患者以 1:1 的比例随机分为口服奥拉帕利和西地尼布（干预组）或单独口服奥拉帕利（对照组）。
主要纳入标准
患者已知诊断为高级别浆液性或子宫内膜样卵巢、输卵管或腹膜癌，在一线铂类化疗后 6 个月以上进展，对二线铂类化疗有反应。
主要终点
无进展生存期和总生存期。使用固定序列门控方法评估共同主要终点：（1）所有患者的无进展生存期；（2）BRCA 野生型患者的无进展生存期；（3）所有患者的总生存期；（4）BRCA 野生型患者的总生存期。
样本量
将招募 618 名患者。
预计入组完成时间和结果呈现时间
预计 2024 年完成入组，2025 年呈现结果。
试验注册
ClinicalTrials.gov：NCT03278717。
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