Chinese expert experience in optimizing stage Ⅰ clinical study management of ovarian cancer

吴小华; 张　剑; 尹如铁; 娄　阁; 高雨农

doi:10.19401/j.cnki.1007-3639.2019.05.001

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Chinese expert experience in optimizing stage Ⅰ clinical study management of ovarian cancer

更新时间：2026-01-27

- Chinese expert experience in optimizing stage Ⅰ clinical study management of ovarian cancer
- China Oncology Vol. 29, Issue 5, Pages: 321-327(2019)
- 作者机构：
  
  1. 复旦大学附属肿瘤医院妇瘤科，复旦大学上海医学院肿瘤学系,上海,200032
  2. 复旦大学附属肿瘤医院肿瘤内科，复旦大学上海医学院肿瘤学系,上海,200032
  3. 四川大学华西第二医院妇产科,四川,成都,610041
  4. 哈尔滨医科大学附属肿瘤医院妇科,黑龙江,哈尔滨,150081
  5. 北京肿瘤医院妇瘤科,北京,100142
- 作者简介：
- 基金信息：
- DOI：10.19401/j.cnki.1007-3639.2019.05.001
  CLC： R737.31
- Published Online：03 June 2019，
  
  Published：03 June 2019
- 稿件说明：
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吴小华，张　剑，尹如铁，娄　阁，高雨农. 优化卵巢癌Ⅰ期临床研究管理中国专家经验[J]. 中国癌症杂志, 2019, 29(5): 321-327.

吴小华, 张　剑, 尹如铁, et al. Chinese expert experience in optimizing stage Ⅰ clinical study management of ovarian cancer[J]. China Oncology, 2019, 29(5): 321-327.
吴小华，张　剑，尹如铁，娄　阁，高雨农. 优化卵巢癌Ⅰ期临床研究管理中国专家经验[J]. 中国癌症杂志, 2019, 29(5): 321-327. DOI： 10.19401/j.cnki.1007-3639.2019.05.001.

吴小华, 张　剑, 尹如铁, et al. Chinese expert experience in optimizing stage Ⅰ clinical study management of ovarian cancer[J]. China Oncology, 2019, 29(5): 321-327. DOI： 10.19401/j.cnki.1007-3639.2019.05.001.

摘要

卵巢癌是中国妇科恶性肿瘤主要的死亡原因之一。随着国际上抗肿瘤治疗的迅速发展，国内的抗肿瘤新药也不断涌现，高效地开展相关临床研究将为患者带来极大的获益。基于中国尼拉帕尼的卵巢癌Ⅰ期临床研究（编号为ZL-2306-002），中国专家从患者知情同意、入排审核、临床用药随访、数据管理、不良反应处理和患者关爱等维度进行了总结和讨论，并对国内开展的卵巢癌Ⅰ期临床研究进行了分析，旨在为国内抗肿瘤新药临床研究的开展提供参考与经验。

Abstract

Ovarian cancer is one of the main causes of death among gynecological malignancies in China. With the rapid development of antineoplastic therapies worldwide

new drugs are emerging one afrer another in China. Carrying out the relevant clinical studies scientifically and efficiently will bring great benefits to the patients. Based on the stage Ⅰ clinical study of niraparib in China (No. ZL-2306-002)

Chinese experts summarized and discussed it from the perspectives of getting informed consent

auditing patient recruitment

follow-up of clinical medication

data management

adverse reaction management and patient care. Meanwhile

the present condition of stage Ⅰ study of ovarian cancer in China was analyzed

aiming to provide reference and experience for the development of clinical study of novel antineoplastic drugs in China.

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Department of Clinical Laboratory, Fudan University Shanghai Cancer Center; Department of Oncology, Shanghai Medical College, Fudan University

Department of Gynecological Oncology, Fudan University Shanghai Cancer Center; Department of Oncology, Shanghai Medical College, Fudan University

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Department of Obstetrics and Gynecology, Obstetrics and Gynecology Hospital, Fudan University

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