Prospective, Open, One-arm Clinical Study Evaluating the Efficacy and Safety of Pegylated Recombinant Human Granulocyte Stimulating Factor in Secondary Prevention of Albumin Paclitaxel Combined With S-1 in the First-line Treatment of Advanced Pancreatic Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Incidence of degree 3-4 neutropenia in each cycle of chemotherapy
研究概览
简要总结
A prospective, open, one-arm clinical study to evaluate the efficacy and safety of jinyouli in the first-line treatment of advanced pancreatic cancer with albumin paclitaxel combined with S-1.Chemotherapy regimen: (1) chemotherapy: albumin paclitaxel, 120mg / m2, intravenous infusion for 30 minutes, D1. S-1, taken orally after meal, D1 - 14. (2) patients who met the input / discharge criteria were given jinyouli injections 24 hours after the end of intravenous infusion of albumin paclitaxel during the treatment period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) Age ≥ 18 years, ≤70 years;
- •(2) Patients with Advanced Pancreatic Cancer diagnosed by histopathology，the expected survival time is more than 3 months;
- •(3) Neutropenia of ≥2 degree occurred with the albumin paclitaxel + S-1 regimen in the previous cycle.
- •(4) KPS score≥70points;
- •(5) The peripheral blood routine of the patients was normal: ANC ≥ 2.0x109 / L, platelet count ≥ 90 × 109 / L, HB ≥ 80g / L before enrollment, and there was no bleeding tendency;
- •(6) Patients volunteered to participate in the trial and signed a written informed consent to be followed up.
排除标准
- •(1) There are currently hard-to-control infections or systemic antibiotic treatment within 72 h of chemotherapy；
- •(2) Any abnormal bone marrow hyperplasia and other abnormal hematopoietic function；
- •(3) Patients who had received bone marrow or hematopoietic stem cell transplantation within the previous 3 months；
- •(4) Previous patients with other malignant tumors not cured, or brain metastases；
- •(5) Liver function tests total bilirubin (TBIL), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) are >2.5 times the upper limit of normal, if the above indicators are >5 times due to liver metastasis Upper limit of normal value;
- •(6) Renal function test: serum creatinine (Cr) exceeded the upper limit of normal value；
- •(7) Allergic to this product or other biological products derived from genetically engineered escherichia coli；
- •(8) Suffering from a mental or nervous system disorder, lacking self-awareness or coordination；
- •(9) Patients who are expected to have a short survival and have difficulty tolerating chemotherapy；
- •(10) Pregnant and nursing female patients；
- •(11) People who are using other drugs of the same category or are in clinical trials of other drugs；
- •(12) The investigator judges patients who are not suitable for participation.
研究组 & 干预措施
PEG-rhG-CSF
Jin Youli(PEG-rhG-CSF): jinyouli injection was given 24 hours after the completion of intravenous infusion of albumin paclitaxel during the treatment period, 6 mg was given to patients with body weight ≥45 kg, and 3 mg was given for body weight <45 kg. Inject once every chemotherapy cycle
干预措施: PEG-rhG-CSF (Drug)
结局指标
主要结局
Incidence of degree 3-4 neutropenia in each cycle of chemotherapy
时间窗: It lasts 4 cycles(each cycle is 21 days)
Incidence of degree 3-4 neutropenia in each cycle of chemotherapy
次要结局
- Incidence of chemotherapy dose adjustment due to neutropenia in each cycle of chemotherapy(It lasts 4 cycles(each cycle is 21 days))
- The proportion of patients receiving antibiotics during the entire chemotherapy period.(It lasts 4 cycles(each cycle is 21 days))
- The incidence of febrile neutropenia in each cycle of chemotherapy(It lasts 4 cycles(each cycle is 21 days))
- The proportion of patients hospitalized due to neutropenia(It lasts 4 cycles(each cycle is 21 days))