Fluzoparib Combined With Famitinib as Maintenance Therapy After Response to First-Line Platinum-Based Chemotherapy in Patients With Advanced Ovarian Cancer: A Single-Arm, Multicenter Clinical Study
概览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- Jinhua Zhou
- 入组人数
- 43
- 主要终点
- Progression-Free Survival (PFS)
概览
简要总结
This is a single-arm, open-label, multicenter exploratory clinical study designed to evaluate the efficacy and safety of fluzoparib combined with famitinib malate as maintenance therapy in patients with newly diagnosed advanced (FIGO III-IV) high-grade serous or endometrioid ovarian cancer (including fallopian tube and primary peritoneal cancer) who have achieved a complete response (CR) or partial response (PR) after first-line platinum-based chemotherapy (with or without bevacizumab). Eligible women aged 18-75 years with ECOG 0-1 will start study treatment within <9 weeks after the last platinum dose. Participants will receive fluzoparib 150 mg orally twice daily plus famitinib malate 10 mg orally once daily in 28-day cycles, continuing for up to 24 cycles or until disease progression, unacceptable toxicity, initiation of new anti-tumor therapy, withdrawal of consent, or investigator decision. The primary endpoint is progression-free survival (PFS); secondary endpoints include overall survival (OS), duration of response (DOR), time to response (TTR), and PFS-2.
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged 18 to 75 years at the time of informed consent. Newly diagnosed, histologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, including high-grade serous or high-grade endometrioid carcinoma.
- •FIGO stage III-IV disease at initial diagnosis. Achieved complete response (CR) or partial response (PR) after completion of first-line platinum-based chemotherapy, with or without bevacizumab.
- •Initiation of study treatment within 9 weeks after the last dose of platinum-based chemotherapy.
- •ECOG performance status 0-
- •Adequate bone marrow, liver, and renal function, as defined by protocol-specified laboratory criteria.
- •Life expectancy of ≥12 weeks. Ability to swallow oral medications and comply with study requirements. Signed written informed consent prior to any study-specific procedures.
排除标准
- •Evidence of disease progression during or after first-line platinum-based chemotherapy.
- •Prior treatment with any PARP inhibitor or anti-angiogenic tyrosine kinase inhibitor (except bevacizumab as part of first-line therapy).
- •Prior systemic anti-cancer therapy for ovarian cancer other than first-line platinum-based chemotherapy.
- •Uncontrolled or significant cardiovascular disease, including but not limited to uncontrolled hypertension, recent myocardial infarction, or clinically significant arrhythmia.
- •Active or uncontrolled infection, or serious concomitant systemic disorders that may interfere with study participation.
- •Known central nervous system metastases. History of other malignancies within the past 5 years, except for adequately treated carcinoma in situ of the cervix or non-melanoma skin cancer.
- •Pregnant or breastfeeding women. Known hypersensitivity to fluzoparib, famitinib, or any of their excipients. Any condition that, in the investigator's judgment, would make the patient unsuitable for participation in the study.
研究组 & 干预措施
Maintenance Therapy: Fluzoparib + Famitinib
Patients who achieved complete or partial response after first-line platinum-based chemotherapy receive maintenance therapy with fluzoparib plus famitinib malate. Fluzoparib is administered orally at 150 mg twice daily, and famitinib malate is administered orally at 10 mg once daily in 28-day cycles, continued until disease progression, unacceptable toxicity, withdrawal of consent, or completion of up to 24 cycles.
干预措施: Fluzoparib (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: From treatment initiation up to approximately 48 months
Progression-free survival is defined as the time from initiation of maintenance treatment with fluzoparib plus famitinib to the first documentation of disease progression according to RECIST v1.1 criteria or death from any cause, whichever occurs first.
次要结局
未报告次要终点
研究者
Jinhua Zhou
Director, Department of Obstetrics and Gynecology
The First Affiliated Hospital of Soochow University