Efficacy and Safety Phase II Study of Recombinant Human Serum Albumin/Granulocyte Colony-Stimulating Factor Fusion Protein for Injection to Prevent Neutrophilic Granulocytopenia Among Chemotherapy Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 216
- 试验地点
- 1
- 主要终点
- The mean of duration for class IV neutrophilic granulocytopenia
研究概览
简要总结
The purpose of this study is to evaluate the dosages of recombinant human serum albumin/granulocyte colony-stimulating factor fusion protein by injection for preventing neutrophilic granulocytopenia among chemotherapy patients.
Conduct Pharmacokinetics (PK) study on recombinant human serum albumin/granulocyte colony-stimulating factor fusion protein with recombinant human granulocyte colony-stimulating factor injection as a control.
详细描述
- Brief Protocol: Treat the patients taking Taxotere+Epirubicin+Cyclophosphamide (TEC) treatment or Taxotere+Epirubicin (TE) treatment chemotherapy with the study medicine or positive control during the period between two chemotherapy treatments.
- Positive control：recombinant human granulocyte colony-stimulating factor injection.
- Targeted patients: breast cancer
- Grouping: Group 1: 1.2 mg recombinant human serum albumin/granulocyte colony-stimulating factor fusion protein with TEC or TE treatment; Group 2: 1.5 mg recombinant human serum albumin/granulocyte colony-stimulating factor fusion protein with TEC or TE treatment; Group 3: positive control with TEC or TE treatment.
- Number of patients: 216
- Concomitant medicines will be conducted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosed breast cancer, suitable for TEC or TE .
- •ECOG performance status 0 or
- •Adjuvant chemotherapy; new adjuvant chemotherapy; newly diagnosed class Ⅳ and prior chemotherapy.
- •ANC≥1.5×10 9/L, PLT≥100×10 9/L. No bone marrow metastasis,blood coagulation function normally, no Hemorrhagic tendency.
- •No obvious abnormal ecg examination.
- •TBIL, ALT, AST≤2.5×ULN (≤5×ULN if presence of hepatic metastases).
- •Cr, BUN≤2.5×ULN.
- •Signed informed consent.
排除标准
- •Chemotherapy within past 4 weeks
- •Uncontrolled inflammatory disease,axillary temperature≥38℃.
- •Merging other malignant tumor
- •Pregnancy or nursing status.
- •Participation in another clinical trial with and investigational product within 3 months prior to study entry.
- •Severe diabetes mellitus, or poor blood sugar controller.
- •Allergic disease or allergic constitution. History of protein allergy.
- •History of drug addiction and alcoholism.
- •Hematopoietic stem cell transplantation or organ transplantation.
- •Chronic disease of severe cardiac, kidney and liver.
- •Other conditions that would be excluded from this study according to doctors'judgment
研究组 & 干预措施
Group 1
Intervention: HSA-GCSF 1.2 mg
Drug: TE or TEC TE: Taxotere+Epirubicin Taxotere (75mg/m2) and Epirubicin (75mg/m2), IV on day 1 of each 21 chemotherapy cycle.
TEC:Taxotere+Epirubicin+Cyclophosphamide Taxotere (75mg/m2),Epirubicin (75mg/m2) and Cyclophosphamide (500mg/m2), IV on day 1 of each 21 chemotherapy cycle.
Recombinant Human Serum Albumin/Granulocyte Colony-Stimulating Factor Fusion Protein（1.2mg）will be injected subcutaneously at night o'clock a.m. in the 3rd and 7th day of per chemotherapy cycle. After the injection, stop administrating if Absolute Neutrophil Count (ANC) in peripheral blood exceeded 1.5×109/L at two contiguous times at least. If not up to standard, investigator should decide whether or not the third administration.
干预措施: HSA-GCSF 1.2 mg (Drug)
Group 2
Intervention:HSA-GCSF 1.5 mg
Drug: TE or TEC TE: Taxotere+Epirubicin Taxotere (75mg/m2) and Epirubicin (75mg/m2), IV on day 1 of each 21 chemotherapy cycle.
TEC:Taxotere+Epirubicin+Cyclophosphamide Taxotere (75mg/m2),Epirubicin (75mg/m2) and Cyclophosphamide (500mg/m2), IV on day 1 of each 21 chemotherapy cycle.
Recombinant Human Serum Albumin/Granulocyte Colony-Stimulating Factor Fusion Protein（1.5mg）will be injected subcutaneously at night o'clock a.m. in the 3rd and 7th day of per chemotherapy cycle. After the injection, stop administrating if Absolute Neutrophil Count (ANC) in peripheral blood exceeded 1.5×109/L at two contiguous times at least. If not up to standard, investigator should decide whether or not the third administration.
Intervention: Drug: TE or TEC
干预措施: HSA-GCSF 1.5 mg (Drug)
Group 3
Intervention: GCSF
Drug: TE or TEC TE: Taxotere+Epirubicin Taxotere (75mg/m2) and Epirubicin (75mg/m2), IV on day 1 of each 21 chemotherapy cycle.
TEC:Taxotere+Epirubicin+Cyclophosphamide Taxotere (75mg/m2),Epirubicin (75mg/m2) and Cyclophosphamide (500mg/m2), IV on day 1 of each 21 chemotherapy cycle.
Recombinant Human Granulocyte Colony-Stimulating Factor Injection (5μg/kg/day) will be injected subcutaneously at night o'clock a.m. from the 3rd of per chemotherapy cycle. After the injection, stop administrating if Absolute Neutrophil Count (ANC) in peripheral blood exceeded 1.5×109/L at two contiguous times at least. The maximum of usage was continuous 14 days.
Intervention: Drug: TE or TEC
干预措施: GCSF (Drug)
结局指标
主要结局
The mean of duration for class IV neutrophilic granulocytopenia
时间窗: 4 weeks
次要结局
- febrile neutropenia(8 weeks)
- ANC(8 weeks)
- The mean of duration for class IV neutrophilic granulocytopenia(8 weeks)
- The mean of duration for ANC up to 2.0×109/L(8 weeks)
- The usage of antibiotics(8 weeks)