Efficacy and Safety of Abraxane With Bevacizumab Biosimilar in Patients With Recurrent, Platinum-resistant Epithelial Ovarian Cancer：A Multi-center, Prospective, One-arm, Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- objective response rate
研究概览
简要总结
The study is a multi-center, prospective, one-arm, phase II clinical trial. It is tend to examine the safety and efficacy of combining abraxane(albumin-bound paclitaxel） and bevacizumab to treat patients with recurrent, platinum-resistant primary epithelial ovarian cancer, fallopian tube cancer or peritoneal carcinoma.
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
- •Recurrent or progressive primary EOC, fallopian tube carcinoma or peritoneal carcinoma (PC) within 6 months of their last previous platinum therapy
- •Patients had received at least one prior line of platinum-based chemotherapy
- •Patients were required to have one measurable disease for assessment according to RECIST version 1.1 or determined CA125 level according to GCIG
- •Eastern Cooperative Oncology Group (ECOG) Performance Status rating of 0-1
- •life expectancy ≥3 months
- •≥30 days after surgery, the body has recovered and there is no active infection
- •Patients had received at least 1 prior line of platinum-based chemotherapy and were recurrent or progressed within 6 months after the end of the last platinum-based regimen
- •Must have adequate hematologic and hepatic function
- •Subjects of childbearing age must agree to use effective contraception during the trial period and negative for serum or urine pregnancy test
- •Patient provides voluntary written informed consent
排除标准
- •Previously received bevacizumab.
- •History of other invasive malignancy with the exception of nonmelanoma skin cancer
- •Participate in other drug trials
- •Blood pressure of >150/100 mmHg on antihypertensive medications
- •Previous history of hypertensive crisis or hypertensive encephalopathy
- •Diagnosed with unstable angina per NYHA or Grade 2 or greater congestive heart failure
- •The history of myocardial infarction within 6 months
- •The history of stroke or transient ischemic attack within 6 months of enrollment
- •Clinically significant vascular disease (e.g., aortic aneurysm, aortic dissection) or symptomatic peripheral vascular disease
- •Bleeding diathesis or coagulopathy
- •Presence of central nervous system or brain metastases
- •Pre-existing peripheral neuropathy of Grade ≥ 2
- •Major surgery was performed within 28 days prior to enrollment
- •Partial or complete ileus within 3 months prior to study enrollment
- •A biopsy or other minor surgery within 7 days prior to study enrollment
- •Positive pregnancy test or is lactating
- •Abdominal fistula, gastrointestinal perforation or abscess accumulation in the abdominal cavity within 6 months prior to study enrollment
- •Severe, nonhealing wound, ulcer, or bone fracture
- •Serious intercurrent medical or psychiatric illness, including serious active infection
- •Uncontrolled systemic infections require antiinfective treatment
- •Proteinuria at screening as demonstrated by either
- •Urine protein:creatinine (UPC) ratio ≥ 1.0 at screening OR
- •Urine dipstick for proteinuria ≥ 2+ (patients discovered to have ≥2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate ≤ 1g of protein in 24 hours to be eligible)
- •Known to be allergic, highly sensitive or intolerant to investigational drugs or their excipients
研究组 & 干预措施
albumin-bound paclitaxe combined with bevacizumab biosimilar
albumin-bound paclitaxel, 260mg/m2，ivdrip，D1，once every three weeks bevacizumab biosimilar, 10mg/kg，ivdrip，D1, once every three weeks
干预措施: albumin-bound paclitaxe combined with bevacizumab biosimilar (Drug)
结局指标
主要结局
objective response rate
时间窗: Assessed at the end of 6 cycle(each cycle is 21 days)
Radiologic imaging was scheduled to be performed at baseline, after every third treatment cycle, and at the end of treatment or time of progression unless it was done in the previous four weeks. Response was evaluated using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is \>=30% decrease in the sum of the longest diameter of target lesions; objective response rate (ORR) = CR+PR
次要结局
- 6-month progression-free survival rate(assessed up to 6 months)
- progression-free survival(up to 3 years)
- overall survival(assessed up to 3 years)
- Disease control rate(Assessed at the end of 6 cycle(each cycle is 21 days))
研究者
Beihua Kong
Head of gynaecology and obstetrics
Shandong University