A Prospective Study of Bevacizumab Combined With Fluzoparib, Bevacizumab Combined With Chemotherapy or Fluzoparib Monotherapy in the Treatment of Platinum-resistant Recurrent Ovarian Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Progression-Free-Survival
研究概览
简要总结
This study was designed to explore the safety and efficacy of Bevacizumab combined with Fluzoparib, Bevacizumab combined with chemotherapy or Fluzoparib monotherapy in patients with platinum-resistant recurrent ovarian cancer.
详细描述
This purpose of this study is to explore efficacy of Bevacizumab combined with Fluzoparib, Bevacizumab combined with chemotherapy or Fluzoparib monotherapy in patients with platinum-resistant recurrent ovarian cancer.Besides the efficacy,we focus on the safety and quality of life in the new treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Age ≥18 years, female;
- •Recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer proven to be platinum-resistant by histology or cytology;
- •ECOG score was 0-1;
- •Expected survival time > 12 weeks;
- •Normal or abnormal bone marrow, kidney, and liver function of the patient has no clinical significance, and the specific situation will be comprehensively determined by the investigator;
- •Patients not previously treated with PARPi or targeted drugs;
- •The patient has taken effective contraceptive measures within 14 days prior to screening and is willing to sign the notification until the last medication No pregnancy plan and voluntary use of effective contraceptive measures within the next 6 months;
- •The subject or his/her legal guardian can communicate well with the investigator, understand and comply with the requirements of this study, and understand and sign the informed consent.
排除标准
- •Known allergy to fluzopalil or study drug components;
- •Patients with any factors affecting oral administration (such as previous gastric or small bowel resection, or current atrophic gastritis, chronic intestinal disease, gastrointestinal bleeding, dysphagia, gastrointestinal obstruction, or diarrhea greater than grade 1, including those who have recovered but have not recovered);
- •Patients who underwent major surgery or gastrointestinal surgery affecting drug absorption, open biopsy, severe traumatic injury, wound unhealed or did not recover from major surgery within 1 month before the trial;
- •Before the first administration, patients have used strong CYP3A inhibitors (such as itraconazole, telithromycin, clarithromycin, ritonavir, etc.) or medium CYP3A inhibitors (such as ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil, etc.); Patients who had used strong CYP3A inducers (e.g., phenobarbide, enzyluamide, phenytoin, rifampicin, rifambutin, rifapentine, carbamazepine, nevirapine and St. John's herb) or medium CYP3A inducers (e.g., Bosentan, efavirenz, modafinil, etc.) and did not reach 3 elimination half-lives;
- •Pregnant or lactating women or subjects who cannot use contraception as required;
- •Those who have special requirements on diet and cannot accept uniform diet;
- •As judged by the researcher, there are other circumstances that are not suitable for the researcher.
研究组 & 干预措施
Bevacizumab combined with Fluzoparib
Bevacizumab combined with Fluzoparib will be administered in patients with platinum-resistant recurrent ovarian cancer.
干预措施: Bevacizumab (Drug)
Bevacizumab combined with Fluzoparib
Bevacizumab combined with Fluzoparib will be administered in patients with platinum-resistant recurrent ovarian cancer.
干预措施: chemotherapy (Drug)
Bevacizumab combined with chemotherapy
Bevacizumab combined with non-platinum chemotherapy will be administered in patients with platinum-resistant recurrent ovarian cancer.
干预措施: Bevacizumab (Drug)
Bevacizumab combined with chemotherapy
Bevacizumab combined with non-platinum chemotherapy will be administered in patients with platinum-resistant recurrent ovarian cancer.
干预措施: chemotherapy (Drug)
Fluzoparib
Fluzoparib monotherapy will be administered in patients with platinum-resistant recurrent ovarian cancer.
干预措施: Fluzoparib (Drug)
结局指标
主要结局
Progression-Free-Survival
时间窗: 2 years
The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse
次要结局
- Overall Survival(2 years)
- Objective remission rate(2 years)
- Adverse event Adverse event(2 years)