A Real-world Study of on Albumin-bound Paclitaxel as First-line Treatment of Patients With Non-operative Locally Advanced or Metastatic Pancreatic Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Progression free survival
研究概览
简要总结
Pancreatic cancer progresses rapidly and has a higher death rate. Albumin-bound paclitaxel is a new generation of paclitaxel . Albumin-bound paclitaxel is recommended as a class 1A evidence treating patients with pancreatic cancer.The purpose of this study was to further observe and evaluate the clinical efficacy and safety of albumin-bound paclitaxel in the treatment of non-operative locally advanced or metastatic pancreatic cancer and to explore the prognostic factors .
详细描述
This is a prospective, single-arm, observational study. After the subjects meet the inclusive and exclusive criteria, then they will receive albumin-bound paclitaxel treatment. The researchers can choose the treatment based on albumin-bound paclitaxel and choose dosage according to the patient's condition.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18 -80, male or female;
- •Non-operative patients with locally advanced or metastatic pancreatic cancer diagnosed by pathology or histology (except islet cell carcinoma);
- •The patient has not received standard systematic treatment in the past, and the metastatic site has not received any local treatment, including radiotherapy, chemotherapy, surgical treatment, etc.;
- •At least one measurable lesion (CT scan length of tumor lesion is greater than 10 mm, CT scan short diameter of lymph node lesion is greater than 15 mm, scanning layer thickness is not greater than 5 mm);
- •The subjects volunteered to participate in this study and signed the informed consent form, with good compliance to follow-up.
排除标准
- •Pregnant or lactating women;
- •Patients allergy to albumin-bound paclitaxel or its excipients
- •Patients with albumin-bound paclitaxel contraindication;
- •Doctors consider those who are not suitable for this study.
结局指标
主要结局
Progression free survival
时间窗: 3 weeks
the date from enrollment to the first occurrence of disease progression or death from any cause, whichever occurs first.
次要结局
未报告次要终点
研究者
Baorui Liu
chief doctor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School