NCT03977077Unknown不适用
A Retrospective Clinical Study on the Efficacy and Safety of Injection Taxol (Albumin Binding Type) in the Treatment of Patients With Advanced Gastrointestinal Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Progression free survival (PFS)
研究概览
简要总结
The purpose of this study was to evaluate the safety and efficacy of domestic injection paclitaxel (albumin binding type) in patients with advanced digestive tract tumors,and to further explore the possible predictors of efficacy.In order to provide more effective chemotherapeutic drugs, prolong survival time and improve quality of life for patients with advanced digestive tract tumors.
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
- •Patients aged ≥18 years with advanced esophageal cancer, gastric cancer, pancreatic cancer and gallbladder (duct) confirmed histologically by albumin paclitaxel chemotherapy regimen;
- •ECOG PS 0-2；
- •Expected survival time ≥3 months;
- •According to RECIST1.1, at least one measurable lesion exists；
- •The level of organ function must meet the following requirements（1）Blood routine examination standards must be met：HB≥90 g/L；ANC≥1.5×109/L； PLT≥80×109/L；（2）Liver function should meet the following criteria TBIL≤1.5×ULN；AST≤2.5×ULN；（3）Renal function should meet the following criteria: CrCL≥60 ml/min；
排除标准
- •Pregnant or lactating women；
- •Had a history of other primary malignancies within 5 years, with the exception of cured basal cell skin cancer and cured cervical cancer;
- •Active brain metastasis or severe disease;
- •Grade 1 peripheral neuropathy (judged according to NCICTC standard for adverse reactions);
- •Patients with allergy to research drugs, albumin or previous allergies;
- •Severe mental or neurological disorders affecting the presentation or observation of adverse reactions;
- •The investigator considers that there is any condition that may impair the subject or cause the subject to fail to meet or perform the study requirements.
研究组 & 干预措施
Albumin binding taxol
Experimental
干预措施: Albumin binding taxol (Drug)
结局指标
主要结局
Progression free survival (PFS)
时间窗: up to 2 year
Progression free survival (PFS) is the time between the onset of treatment and the observation of disease progression or death from any cause.
次要结局
- Objective remission rate (ORR)(up to 2 year)
- Overall survival(up to 2 year)
研究者
研究点 (1)
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