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临床试验/NCT05310344
NCT05310344Unknown2 期

Albumin-bound Paclitaxel and Bevacizumab for Platinum-resistant Recurrent Epithelial Ovarian Cancer: A Single-arm, Multi-center, Phase II Clinical Study

Lei Li1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年3月27日最近更新:
适应症

试验速览

阶段
2 期
发起方
入组人数
50
试验地点
1
主要终点
Objective response rate (ORR)

研究概览

简要总结

This study is a prospective, multicenter, phase II clinical trial to evaluate the efficacy and safety of albumin-bound paclitaxel combined with bevacizumab for platinum-resistant recurrent epithelial ovarian cancer. Patients with platinum-resistant recurrent ovarian cancer who meet the inclusion criteria, and don't meet any of the exclusion criteria, are enrolled in the study. They will receive albumin-bound paclitaxel (260 mg/m2) and bevacizumab (7.5mg/kg) intravenously every 21 days. Treatment continue until disease progression, intolerable toxicity, or patient refusal. Objective response rates primary objective. Progression-free survival, overall survival, and safety are secondary objectives. The study will enroll a total of 50 patients.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Objective response rate (ORR)

时间窗: 24 months

ORR is defined as the percentage of participants in the analysis population who have a complete or partial remission per RECIST 1.1

次要结局

  • Adverse Events(36 months)
  • Progression-Free Survival (PFS)(24 months)
  • Overall survival(36 months)

研究者

发起方
Lei Li
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Lei Li

Professor

Peking Union Medical College Hospital

研究点 (1)

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