A Phase I Study of Chemoradiotherapy Using Gemcitabine Plus Nab-paclitaxel for Unresectable Locally Advanced Pancreatic Adenocarcinoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Number of patients with Adverse Events
研究概览
简要总结
The purpose of this study is to evaluate the clinical safety and efficacy of Gemcitabine plus nab-Paclitaxel chemoradiotherapy and to determine the Maximal Tolerated Dose (MTD) for unresectable locally advanced pancreatic adenocarcinoma.
详细描述
Gemcitabine plus nab-Paclitaxel is one of the standard chemotherapy for metastatic pancreatic adenocarcinoma. Gemcitabine plus nab-Paclitaxel realize the favorable anti-tumor effect and tolerable toxicity. Gemcitabine plus nab-Paclitaxel is a promising regimen for concurrent chemoradiotherapy, but the investigators need to know the safety in the case of the concurrent chemoradiotherapy.
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed advanced pancreatic cancer
- •Locally advanced pancreatic cancer is defined as the presence of a surgically unresectable tumor(involving the celiac axis or the superior mesenteric artery)
- •Performance Status:0-1(ECOG)
- •Patients of age =>20 and 75>
- •White Blood Cell (WBC) >=3,500/mm3,12,000/mm3,
- •Neutrophils >=1,500/mm3, platelets=100,000/mm3,
- •Hemoglobin >=9.5 g/dl,
- •GOT </=2.0 X Upper Limit Number (ULN),
- •Glutamate Pyruvate Transaminase (GPT) </=2.0 X ULN,
- •Alkaline Phosphatase (ALP) </=2.0 X ULN,
- •Total bilirubin <=1.5mg/dl,
- •Serum creatinine <=1.2mg/dl,
- •Creatinine clearance>=50 ml/min
- •arterial O2 pressure (PaO2) >=70torr or arterial O2 saturation (SpO2) >=96%
- •Life expectancy more than 3 months.
- •Written informed consent.
排除标准
- •Active infection
- •Lung fibrosis or intestinal pneumonia detectable on chest X-ray and CT
- •Severe complication (heart disease, cirrhosis, diabetes)
- •Myocardial infarction within 3 months
- •Active synchronous or metachronous malignancy
- •Pregnant or lactation women, or women with known or suspected pregnancy
- •Symptomatic brain metastasis
- •History of severe drug allergy
- •Peripheral neuropathy
- •Patients who are judged inappropriate for the entry into the study by the investigator
研究组 & 干预措施
Gemcitabine, Nab-Paclitaxel
A conformal phase I study using 3 plus 3 method.
Chemoradiotherapy while Gemcitabine, Nab-Paclitaxel are administered.
Both Gemcitabine and Nab-Paclitaxel are an interventional agents in this arm.
Gemcitabine is administered with 30 min intravenous infusion on day 1,8 and 15 every 4 weeks.
Nab-Paclitaxel is administered with 30 min intravenous infusion on day 1,8 and 15 every 4 weeks.
Radiotherapy (a total dose of 50.4Gy) was delivered in 28 fractions.
干预措施: Gemcitabine (Drug)
Gemcitabine, Nab-Paclitaxel
A conformal phase I study using 3 plus 3 method.
Chemoradiotherapy while Gemcitabine, Nab-Paclitaxel are administered.
Both Gemcitabine and Nab-Paclitaxel are an interventional agents in this arm.
Gemcitabine is administered with 30 min intravenous infusion on day 1,8 and 15 every 4 weeks.
Nab-Paclitaxel is administered with 30 min intravenous infusion on day 1,8 and 15 every 4 weeks.
Radiotherapy (a total dose of 50.4Gy) was delivered in 28 fractions.
干预措施: Nab-Paclitaxel (Drug)
结局指标
主要结局
Number of patients with Adverse Events
时间窗: 1 years
次要结局
- Overall Survival time(2 years)
- Response Rate(1 years)