An Open-label, Phase II Clinical Trial of of a Chinese Patent Medicine Yangzhengxiaoji Capsule to Improve the Adverse Reactions Nausea of Niraparib in in the First-line Maintenance Treatment in Advanced Epithelial Ovarian Cancer (EOC) Patients
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Incidence of nausea
研究概览
简要总结
This study is an open-label, single-Arm， phase II clinical trial of a Chinese Patent Medicine Yangzheng Xiaoji Capsule to improve the adverse reaction nausea of Niraparib in the first-line maintenance treatment in advanced epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer.
详细描述
This study will investigate a Chinese Patent Medicine Yangzheng Xiaoji Capsule improve the adverse reaction nausea of Niraparib in the first-line maintenance treatment in advanced EOC, who have previously received ≥ 3 cycles of prior combined bevacizumab chemotherapy and a complete or partial response with platinum-based chemotherapy.
Approximately 50 eligible subjects are planned to be enrolled, given Yangzheng Xiaoji Capsule and niraparib maintenance treatment.
The dosing regimen is:Niraparib 200mg QD combined with Yangzheng Xiaoji Capsule 0.36g*4 tid，28 days/cycle. Subjects will receive Niraparib plus Yangzheng Xiaoji Capsule up to 3 cycles.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Sign a written informed consent form before conducting any research-related procedures;
- •Women aged 18 or above;
- •Ovarian cancer, fallopian tube cancer or primary peritoneal cancer diagnosed histologically can be treated with Niraparib after evaluation by clinicians;
- •Life expectancy > 3 months;
- •Patients' ECOG physical condition score is 0-1, KPS score is ≥70;
- •Patients received ≥ 3 cycles bevacizumab in combination within platinum-based chemotherapy
- •Good organ function, including:
- •Neutrophil count ≥ 1500/L
- •Platelet ≥ 100,000/L
- •Hemoglobin ≥10g/dL
- •Serum creatinine ≤1.5 times the upper limit of normal value, or creatinine clearance ≥60mL/min (according to Cockcroft-Gault Formula calculation)
- •Total bilirubin ≤1.5 times the upper limit of normal value or direct bilirubin ≤1.0 times the upper limit of normal value
- •AST and ALT ≤2.5 times the upper limit of normal value, and liver metastasis must be ≤5 times the upper limit of normal value.
- •No serious abnormalities of heart, brain, lung, liver and kidney function;
- •No serious mental illness;
- •Ability to comply with the plan;
- •the toxic and side effects of any previous chemotherapy have recovered to ≤CTCAE 1 grade or baseline level, except for sensory neuropathy or alopecia with stable symptoms ≤CTCAE 2 grade.
排除标准
- •People who are allergic to the ingredients in Yangzhengxiaoji Capsule
- •Have undergone major surgery within 3 weeks before the start of the study, or have not recovered any surgical effects after surgery, or have received chemotherapy.
- •patients who are combined with other cancers;
- •Patients with severe heart, liver, kidney and hematopoietic diseases; 5 Patients with poor compliance cannot take drugs according to regulations.
研究组 & 干预措施
Arm
Participants received Niraparib 200mg or 300mg QD PO continually combined with Yangzheng Xiaoji capsule， 0.36g*4 tid，28 days as one cycle，up to 3 cycles.
干预措施: Yangzheng Xiaoji (Drug)
Arm
Participants received Niraparib 200mg or 300mg QD PO continually combined with Yangzheng Xiaoji capsule， 0.36g*4 tid，28 days as one cycle，up to 3 cycles.
干预措施: Niraparib (Drug)
结局指标
主要结局
Incidence of nausea
时间窗: 3 cycles (each cycle is 28 days)
all grade of nausea base on CTCAE V5.0
次要结局
- Quality of life changes(3 cycles (each cycle is 28 days))
- PFS rate, PFS, OS and overall response rate (ORR, Overall response rate) at 12, 18 and 24 months(up to 24 months)
研究者
Guonan Zhang
Director, Head of Gynecologic Oncology Center
Sichuan Cancer Hospital and Research Institute