Phase II Study of Albumin Bound Paclitaxel With 5-FU and CF as Second Line in Taxanes Naive Advanced Gastric Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- PFS(Progression-free survival )
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness and safety of albumin bound paclitaxel plus 5-FU and as second-line therapy in the treatment of taxanes naive patients with advanced gastric 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
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed adenocarcinoma of the stomach with inoperable locally advanced or recurrent and/or metastatic disease.
- •Male or female.
- •Previous one line of non-taxane chemotherapy for advanced/metastatic disease.
- •Measurable disease, according to the Response Evaluation Criteria in Solid Tumours(RECIST)
- •ECOG Performance status 0, 1 or 2
- •Haematological, Biochemical and Organ Function: Neutrophil count >2.0 × 10 9/L, platelet count > 100 ×10 9/L. Serum bilirubin< 1.5 × upper limit of normal (ULN); or, AST or ALT < 2.5 × ULN (or < 5 × ULN in patients with liver metastases); or, alkaline phosphatase< 2.5 × ULN (or > 5 × ULN in patients with liver metastases,Creatinine clearance > 60 mL/min.
- •Signed informed consent.
排除标准
- •No prior chemotherapy for gastric cancer.
- •Received any investigational drug treatment within 30 days of start of study treatment.
- •Patients with active gastrointestinal bleeding.
- •Neurological toxicity ≥ grade 2 NCI-CTCAE.
- •Other malignancy within the last 5 years, except for carcinoma in situ of the cervix, or basal cell carcinoma.
- •History or clinical evidence of brain metastases.
- •Serious uncontrolled systemic intercurrent illness, e.g. infections or poorly controlled diabetes.
- •Pregnancy women.
- •Subjects with reproductive potential not willing to use an effective method of contraception.
- •Patients with known active infection with HIV.
- •Known hypersensitivity to any of the study drugs
研究组 & 干预措施
Albumin Bound Paclitaxel With 5-FU/CF
Albumin Bound Paclitaxel 150 mg/m2 (on day 1),5FU 400 mg/m2 iv d1, 2.4g/ m2 civ,d1-d3 every 2 weeks until disease progress or intolerable toxicity.
干预措施: Albumin Bound Paclitaxel (Drug)
Albumin Bound Paclitaxel With 5-FU/CF
Albumin Bound Paclitaxel 150 mg/m2 (on day 1),5FU 400 mg/m2 iv d1, 2.4g/ m2 civ,d1-d3 every 2 weeks until disease progress or intolerable toxicity.
干预措施: 5-FU (Drug)
结局指标
主要结局
PFS(Progression-free survival )
时间窗: 80% PFS events,, an expected average of 10 months
The PFS was calculated from the initiation of chemotherapy to the date of disease progression or death
次要结局
- OS (Overall survival )(OS follow-up period: 18 months or 80% OS events, whichever occurs first)
研究者
Ruihua Xu
Professor of Medical Oncology,Vice-president of Sun Yat-sen University Cancer Center
Sun Yat-sen University