NCT04518800Unknown不适用
Prospective, Open, Single-arm Clinical Study Evaluating the Efficacy and Safety of PEG-rhG-CSF in Secondary Prevention of Nab-Paclitaxel Combined With S-1 in the First-line Treatment of Advanced Pancreatic Cancer
Chinese PLA General Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年8月18日最近更新:
适应症
干预措施
相关药物
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, single-arm clinical study to evaluate the efficacy and safety of jinyouli（PEG-rhG-CSF） in the first-line treatment of advanced pancreatic cancer with nab-paclitaxel combined with S-1.Chemotherapy regimen: (1) chemotherapy: nab-paclitaxel, 260mg/m2, intravenous infusion for 30 minutes, D1, Q3W. S-1, 80-120mg, PO BID, D1-14, Q3W. (2) patients who met the eligibility criteria were given jinyouli injections 24 hours after the end of intravenous infusion of nab-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
- •Age ≥ 18 years, ≤70 years;
- •Patients with Advanced Pancreatic Cancer diagnosed by histopathology，the expected survival time is more than 3 months;
- •Neutropenia of ≥2 degree occurred with the nab-paclitaxel + S-1 regimen in the previous cycle.
- •KPS score≥70;
- •The peripheral blood routine of the patients was normal: ANC ≥ 2.0x10^9/L, platelet count ≥ 90x10^9/L, HB ≥ 80g/L before enrollment, and there was no bleeding tendency;
- •Patients volunteered to participate in the trial, signed a written informed consent, willing to be followed up.
排除标准
- •There are uncontrollable infections at the moment or systemic antibiotic treatment within 72 h of chemotherapy；
- •Any abnormal bone marrow hyperplasia and other abnormal hematopoietic function；
- •Patients who had received bone marrow or hematopoietic stem cell transplantation within 3 months；
- •Patients with other malignancies that have not been cured or with brain metastases；
- •Total bilirubin(TBIL), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >2.5 ULN, or >5 ULN if there is liver metastasis;
- •Serum creatinine (Cr) exceeded the upper limit of normal value；
- •Allergic to this product or other biological products derived from genetically engineered escherichia coli；
- •Suffering from a mental or nervous system disorder, without self-awareness or coordination；
- •Patients expected to have a short survival or have difficulty tolerating chemotherapy；
- •Pregnant or lactating female patients；
- •Patients using other drugs of the same category or in clinical trials of other drugs；
- •Not suitable for participation at investigators' discretion.
研究组 & 干预措施
Jin Youli(PEG-rhG-CSF)
Experimental
PEG-rhG-CSF Secondary Prevention：patients with pancreatic cancer who met the eligibility criteria were given secondary prophylactic administration of the Jin Youli(PEG-rhG-CSF).
干预措施: Jin Youli(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: last 4 cycles(each cycle is 21 days)
Incidence of degree 3-4 neutropenia in each cycle of chemotherapy
次要结局
- The proportion of patients receiving antibiotics during the entire chemotherapy period.(last 4 cycles(each cycle is 21 days))
- The incidence of febrile neutropenia in each cycle of chemotherapy(last 4 cycles(each cycle is 21 days))
- Incidence of chemotherapy dose adjustment due to neutropenia in each cycle of chemotherapy(last 4 cycles(each cycle is 21 days))
- The proportion of patients hospitalized due to neutropenia(last 4 cycles(each cycle is 21 days))
研究者
Dai, Guanghai
Professor and chief physician
Chinese PLA General Hospital
研究点 (1)
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