NCT06394492招募中3 期
A Randomized, Open-Label, Controlled, Phase III Study of SHR-A1921 Versus Investigator's Choice of Chemotherapy in Patients With Platinum-Resistant Recurrent Epithelial Ovarian Cancer
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 440
- 试验地点
- 2
- 主要终点
- Progression-free Survival (PFS) assessed by Blinded Independ Review Committee (BIRC) as per RECIST 1.1
研究概览
简要总结
This study is a randomized, open-label, controlled, phase III study to evaluate the efficacy and safety of SHR-A1921 versus investigator's choice of chemotherapy in patients with platinum-resistant recurrent epithelial ovarian cancer.
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
- •Voluntary participation and written informed consent.
- •18 years and older, female.
- •Pathologically diagnosed epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
- •Patients must have platinum-resistant disease
- •Be able to provide fresh or archived tumour tissue.
- •At least one measurable lesion according to RECIST v1.
- •Eastern Cooperative Oncology Group (ECOG) score: 0-
- •With a life expectancy ≥ 12 weeks.
- •Adequate bone marrow reserve and organ function.
- •Contraception is required during the trial.
排除标准
- •Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion with clinical symptoms.
- •Previous or co-existing malignancies.
- •Current or History of ILD.
- •Clinical symptoms or diseases of the heart that are not well controlled.
- •Arterial/venous thrombosis events occurred before the first dose.
- •Grade ≥2 bleeding events of CTCAE occurred before the first dose.
- •Gastrointestinal perforation or fistula, urethral fistula, abdominal abscess occurred before the first dose.
- •Patients with intestinal obstruction or parenteral nutrition before the first dose.
- •Serious infection before the first dose.
- •Active hepatitis B or active hepatitis C.
- •Received systemic anticancer treatments 4 weeks prior to the initiation of the study treatment.
- •Treated with TOP1 inhibitors or ADCs with TOP1 inhibitors as payload.
- •Unresolved CTCAE ≥grade 2 toxicities from previous anticancer therapy.
- •History of severe hypersensitivity reactions to either the drug substances or inactive ingredients of SHR-A
- •Other inappropriate situation considered by the investigator.
研究组 & 干预措施
Treatment group 1: SHR-A1921
Experimental
干预措施: SHR-A1921 (Drug)
Treatment group 2: Investigator's choice of chemotherapy
Active Comparator
干预措施: Doxorubicin (Drug)
Treatment group 2: Investigator's choice of chemotherapy
Active Comparator
干预措施: Paclitaxel (Drug)
Treatment group 2: Investigator's choice of chemotherapy
Active Comparator
干预措施: Topotecan (Drug)
结局指标
主要结局
Progression-free Survival (PFS) assessed by Blinded Independ Review Committee (BIRC) as per RECIST 1.1
时间窗: Screening up to study completion, an average of 1 year
次要结局
- CA-125 Response Rate assessed by the Gynaecologic Cancer Intergroup (GCIG) criteria(Screening up to study completion, an average of 1 year)
- Adverse Events(Screening up to study completion, an average of 1 year)
- Disease Control Rate (DCR), assessed by site investigator as per RECIST 1.1(Screening up to study completion, an average of 1 year)
- Objective Response Rate (ORR), assessed by site investigator as per RECIST 1.1(Screening up to study completion, an average of 1 year)
- Duration of Response (DoR), assessed by site investigator as per RECIST 1.1(Screening up to study completion, an average of 1 year)
- Overall Survival (OS)(Screening up to study completion, an average of 1 year)
- Response Rate (RR) assessed by RECIST 1.1 and Gynaecologic Cancer Intergroup (GCIG) criteria(Screening up to study completion, an average of 1 year)
研究者
研究点 (2)
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