Albumin-bound Paclitaxel and Bevacizumab for Platinum-resistant Recurrent Epithelial Ovarian Cancer: A Single-arm, Multi-center, Phase II Clinical Study
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
- 否
入选标准
- •Aged 18~75 years old
- •Histologically confirmed platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer
- •At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;
- •Sufficient bone marrow function;
- •Sufficient liver and renal function;
- •Patients of reproductive potential were required to take effective contraceptive measures for the duration of the study and had a negative serum or urine pregnancy test result; non-lactating women;
- •Patients had no disturbance of consciousness and volunteered to participate in the study.
排除标准
- •Uncontrolled hypertension
- •Tumor invading vital blood vessels
- •With contraindications to chemotherapy
- •With uncontrolled infection
- •Patients had received anticancer therapy within 3 weeks before enrollment
- •Patients were allergic or intolerant to investigational drugs or its ingredients
- •Patients are not suitable for this trial as judged by investigators
研究组 & 干预措施
Patients with platinum-resistant recurrent epithelial ovarian cancer
干预措施: Albumin-bound paclitaxel and bevacizumab (Combination Product)
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
Lei Li
Professor
Peking Union Medical College Hospital