NCT03818282尚未招募2 期
Efficacy and Safety of Paclitaxel for Injection (Albumin-bound) in Combination With Carboplatin for First-line Chemotherapy of Ovarian Cancer: A Multicenter, Open-label, Single-arm Phase 2 Clinical Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 77
- 主要终点
- Progression free Survival
研究概览
简要总结
Preliminary evaluation of the efficacy and safety of paclitaxel for injection (albumin-bound) in combination with carboplatin for first-line chemotherapy of ovarian cancer.
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
- •Age: 18 to 75 years;
- •Histologically confirmed epithelial ovarian cancer, fallopian tube cancer and primary peritoneal cancer;
- •Patients with stage IC-IV according to the International Federation of Obstetrics and Gynecology (FIGO) and who underwent an ideal tumor reduction procedure within 6 weeks prior to enrollment;
- •Lesion is measurable according to RECIST 1.1 criteria or patient's CA125 is evaluable according to GCIG criteria;
- •ECOG performance status of 0-2;
- •Expected survival ≥ 3 months;
- •Bone marrow function: Neutrophils ≥ 1.5×109/L, platelets ≥ 100×109/L, hemoglobin ≥ 90 g/L;
- •Hepatic and renal function: Serum creatinine ≤ 1.5×ULN; AST and ALT ≤ 1.5×ULN or ≤ 5×ULN in the presence of hepatic metastasis; Total bilirubin ≤ 1.5×ULN, or ≤ 2.5×ULN in patients with Gilbert's syndrome;
- •Must agree to use effective contraception during the trial; Women of childbearing potential must have a negative serum or urine pregnancy test; Non-lactating patients.
排除标准
- •Ovarian low-grade malignant tumor patients;
- •Patients who have received abdominal or pelvic radiotherapy;
- •Patients with central nervous system disease or brain metastases;
- •Other malignancies have occurred within the last 5 years, except for cervical carcinoma in situ, non-melanoma skin cancers that have been cured;
- •Prior Grade ≥ 2 sensory or motor neuropathy;
- •Uncontrolled serious medical conditions that, in the opinion of the investigator, would affect the ability of the subject to receive the study regimen, such as concomitant serious medical conditions, including severe heart disease, cerebrovascular disease, uncontrolled diabetes mellitus, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc.;
- •Known to be hypersensitive, highly sensitive, or intolerant to study-related medications or their excipients;
- •Receive other study drug chemotherapy within 30 days of the first dose of chemotherapy;
- •Patients not suitable for participation in this study judged by investigator.
研究组 & 干预措施
Paclitaxel for injection (albumin-bound)
Experimental
干预措施: Paclitaxel for injection (albumin-bound) (Drug)
结局指标
主要结局
Progression free Survival
时间窗: 2 year
PFS
次要结局
未报告次要终点
研究者
Ding Ma
Director
Huazhong University of Science and Technology
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