Evaluating the Efficacy and Safety of Apatinib With Albumin-bound Paclitaxel in Patients With Platinum-resistant Recurrent Ovarian Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 35
- 主要终点
- ORR
研究概览
简要总结
The study was designed to evaluate the efficacy and safety of apatinib with albumin-bound paclitaxel in patients with platinum-resistant recurrent ovarian cancer.
详细描述
The study is an open, one-arm, prospec will collect 35 patients with platinum-resistant recurrent ovarian cancer treated with apatinib with albumin-bound paclitaxel from 2019 to 2020 in Henan Cancer Hospital.Antiangiogenic treatments have been implicated to play a major role in ovarian cancer (OC). Apatinib, a novel oral antiangiogenic agent targeting vascular endothelial growth factor receptor (VEGFR2), in combination with weekly paclitaxel, may improve clinical outcomes compared with apatinib or paclitaxel alone in patients with refractory or platinum-resistant ovarian cancer.
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, age ≥18 years and ≤70 years, signed informed consent.
- •Platinum resistant ovarian cancer (defined as relapsing within 6 months after the last administration of platinum-based chemotherapy) OR platinum refractory ovarian cancer (defined as progressing while on a platinum-based chemotherapy).
- •At least treated with one line of platinum-based chemotherapy.
- •Imaging confirmed diagnosis of progression occurred after the last treatment before enrollment.
- •Histologically or pathologically confirmed diagnosis of ovarian cancer as primary tumor.
- •Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 version.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •Patients must have a life expectancy of at least 3 months.
- •Patients must have adequate organ function as defined by the following criteria:
- •White blood cell count ≥ 3 x 10^9/L, Absolute neutrophil count (ANC) (≥ 1.5 x 10^9/L), Hemoglobin of ≥ 80 g/L, Platelets ≥ 70 x 10^9/L, Total bilirubin ≤ 1 x upper limit of normal (ULN), AST and ALT ≤ 2 x ULN, Serum creatinine ≤ 1 x ULN.
排除标准
- •1.Had prior exposure to apatinib or has known allegies to any of the excipients.
- •2.Patients with trauma, surgical history, gastrointestinal bleeding, and melena within 1 month prior to treatment.
- •3.Inadequately controlled hypertension. 4.History of abdominal fistula or gastrointestinal perforation within 28 days prior to Day
- •5.Imaging studies suggest that patients with tumors invading important blood vessels.
- •6.Symptomatic central nervous system (CNS) metastasis. 7.History of myocardial infarction, or unstable angina, or New York Heart Association (NYHA) Grade III-IV within 6 months prior to Day 1.
研究组 & 干预措施
albumin-bound paclitaxel+apatinib
albumin-bound paclitaxel:260mg/m2，q3w，d1 apatinib:500mg，qd，po
干预措施: albumin-bound paclitaxel (Drug)
albumin-bound paclitaxel+apatinib
albumin-bound paclitaxel:260mg/m2，q3w，d1 apatinib:500mg，qd，po
干预措施: Apatinib (Drug)
结局指标
主要结局
ORR
时间窗: Baseline up to cycle 4 (assessed at Baseline, at the time of pre-surgery)up to approximately 12 months
Objective Response Rate
次要结局
- PFS(through study completion, an average of 5 year)
- OS(through study completion, an average of 5 year)
- DCR(Baseline up to cycle 4 (assessed at Baseline, at the time of pre-surgery)up to approximately 12 months)