An Open-label, Multicentre, Randomized, Controlled Phase III Clinical Trial Comparing HS-20089 Plus Bevacizumab Versus Investigator's Choice of Platinum-based Chemotherapy Plus Bevacizumab in Patients With Platinum-sensitive Recurrent Ovarian Cancer
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 460
- 试验地点
- 39
- 主要终点
- PFS assessed by BICR
研究概览
简要总结
This is a Phase III study evaluating the efficacy of HS-20089 in combination with bevacizumab versus investigator's choice of platinum-based chemotherapy in combination with bevacizumab in participants with platinum-sensitive recurrent ovarian cancer (PSOC).
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The main criteria are as follows:
- •Female, aged 18 years or older (≥18 years)
- •Willing to voluntarily participate in this clinical trial, understand the study procedures, and able to provide written informed consent
- •Platinum-sensitive recurrence
- •ECOG PS: 0-1
- •Expected survival of more than 12 weeks.
- •Women of childbearing potential must be willing to use appropriate contraceptive measures from the time of signing informed consent until 6 months after the last dose administration and should not be breastfeeding.
- •Must be able to provide sufficient fresh or archived tumor tissue specimens that meet the requirements.
排除标准
- •1. Prior treatment with topoisomerase I inhibitors; cytotoxic chemotherapy agents; small molecule inhibitors; antibody-drug conjugates (ADCs).
- •2. Prior major surgery within 4 weeks prior to radonmization.
- •Residual toxicity from previous treatments graded ≥ Grade 2 according to the Common Terminology Criteria for Adverse Events (CTCAE) version 6.
- •4. History of a second primary malignancy.
- •Pleural effusion/ascites requiring clinical intervention); presence of pericardial effusion.
- •6. Imaging evidence of bowel obstruction or symptoms/signs suggestive of bowel obstruction.
- •7 History of gastrointestinal perforation or fistula, or any grade of intra-abdominal abcess within 3 months prior to randonmization.
- •8 Participants known to have central nervous system (CNS) metastases and/or carcinomatous meningitis, either previously diagnosed or identified during screening.
- •9 Severe or poorly controlled hypertension. 10 Clinically significant bleeding symptoms 11 History of severe arterial/venous thromboembolic events
- •Clinically significant active viral, bacterial, or fungal infections requiring intravenous or oral pharmacological treatment
- •Known presence of an active infectious disease
- •History of interstitial lung disease of any grade
研究组 & 干预措施
Treatment group 1
Experimental，Treatment group 1: HS-20089 in combination with Bevacizumab, administered according to the study protocol and as assessed by the investigator.
干预措施: HS-20089+Bevacizumab (Drug)
Treatment group 2-4
Active Comparator，Treatment group 2-4，Carboplatin+Paclitaxel/Gemcitabine/Doxorubicin Hydrochloride Liposome+Bevacizumab：administered according to the study protocol and as assessed by the investigator
干预措施: Dose 2：arboplatin+Paclitaxel+Bevacizumab (Drug)
Treatment group 2-4
Active Comparator，Treatment group 2-4，Carboplatin+Paclitaxel/Gemcitabine/Doxorubicin Hydrochloride Liposome+Bevacizumab：administered according to the study protocol and as assessed by the investigator
干预措施: Dose 3：arboplatin+Gemcitabine+Bevacizumab (Drug)
Treatment group 2-4
Active Comparator，Treatment group 2-4，Carboplatin+Paclitaxel/Gemcitabine/Doxorubicin Hydrochloride Liposome+Bevacizumab：administered according to the study protocol and as assessed by the investigator
干预措施: Dose 4：arboplatin+Doxorubicin Hydrochloride Liposome+Bevacizumab (Drug)
结局指标
主要结局
PFS assessed by BICR
时间窗: Screening up to 3years
Progression-free Survival (PFS) assessed by blinded independent central review (BICR) according to RECIST v1.1 criteria in the ITT population
次要结局
- PFS assessed by the investigator(Screening up to 3 years（Planned date）)
- OS(Through study completion, an average of 5 years)
- ORR(Screening up to study completion，with an average of 5 years)
- DCR(Screening up to study completion, with an average of 5 years)
- DoR(Screening up to study completion, with an average of 5 years)
- TFST(Screening up to study completion, with an average of 5 years)
- PSF2(Screening up to study completion, with an average of 5 years)