NCT06711523进行中（未招募）3 期
A Phase III Clinical Study of the Efficacy and Safety of Polyethylene Glycolized Human Granulocyte Stimulating Factor Injection (PEG-G-CSF) in Preventing Neutropenia After Chemotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Duration of 4th degree neutropenia during chemotherapy cycle 1
研究概览
简要总结
To evaluate the efficacy, safety, and immunogenicity of PEG-G-CSF Injection (Kexing Biopharmaceutical Co., Ltd.) for the prevention of neutropenia after chemotherapy, using the PEG-G-CSF Injection ( Neulasta®, Amgen Europe B.V.) as a positive control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years, ≤75 years
- •Female breast cancer patients with a pathohistologically confirmed diagnosis requiring first-time adjuvant or neoadjuvant chemotherapy and for whom the following regimens are appropriate: ① EC regimen (epirubicin 90 mg/m2 iv day 1, cyclophosphamide 600 mg/m2 iv day 1) ② TC regimen (cyclophosphamide 600 mg/m2 iv day 1, docetaxel 75 mg/m2 iv day 1) ③ TCb regimen ( docetaxel 75 mg/m2 iv day 1, carboplatin AUC=5 iv day 1); Note: TCb regimens such as the combination of anti-HER2 targeting drugs H (trastuzumab) and P (pertuzumab) can also be included.
- •Physical condition ECOG score ≤ 1;
- •Weight ≥ 45kg;
- •Peripheral blood cell counts eligible for chemotherapy: white blood cell (WBC) count ≥ 3.5 x 109/L, neutrophil count (ANC) ≥ 1.5 x 109/L, hemoglobin (HB) ≥ 90 g/L, platelet (PLT) count ≥ 100 x 109/L, normal coagulation or abnormalities of no clinical significance, and no tendency to bleed;
- •Survival is expected to be 6 months or more;
- •The subject is willing to use an appropriate method of contraception for the duration of the trial;
- •Subjects agreed to follow the trial treatment protocol and visit schedule, enrolled voluntarily, and signed a written informed consent form.
排除标准
- •The subjects who have received radiation therapy within 4 weeks prior to randomization;
- •Those who have received hematopoietic stem cell transplantation or bone marrow transplantation
- •Patients who have been treated with G-CSF analogs or PEG-G-CSF analogs within 4 weeks prior to randomization;
- •Subjects with a history of chronic granulocytic leukemia or myelodysplastic syndromes;
- •People at high risk for ARDS;
- •Patients with unexplained splenomegaly on physical examination and/or CT scan or ultrasound, as well as any condition that may cause splenomegaly (e.g., thalassemia, glandular fever, malaria, etc.);
- •Patients who currently have or have had sickle cell anemia;
- •Those with a combined history of malignant tumors (except for the following: cured non-melanoma skin cancer, cervical cancer in situ, limited prostate cancer, superficial bladder cancer, and other malignant tumors with a disease-free survival period of more than 5 years);
- •Those diagnosed with advanced breast cancer combined with distant metastases;
- •Patients with known cerebrovascular malformations (e.g., cerebral hemangiomas), epilepsy;
- •Patients with severe mental or neurological disorders;
- •Patients with severe cardiovascular disease: history of myocardial infarction within 1 year prior to first administration of study drug; sick sinus syndrome, atrioventricular block II or greater, ventricular fibrillation, torsional ventricular tachycardia, sustained ventricular tachycardia; electrocardiogram indicative of abnormal clinically significant QRS wave lowering; congenital prolonged history of the QT interval; left ventricular ejection fraction <50%; NYHA cardiac function class III or IV; poorly controlled hypertension. Poorly controlled hypertension: blood pressure >160 mmHg systolic and/or >100 mmHg diastolic despite antihypertensive medications; congestive heart failure; stable coronary artery disease; unstable angina pectoris;
- •Liver function indexes: ALT, AST, TBIL ≥1.5 times the upper limit of normal before enrollment; Kidney function indexes: Scr ≥1.5 times the upper limit of normal;
- •Positive for Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb) and peripheral blood Hepatitis B Virus (HBV) DNA test is greater than the normal range; Positive for Hepatitis C Virus (HCV); Positive for Human Immunodeficiency Virus (HIV);
- •Those with a current active infection (and a temperature ≥38°C) or who have received systemic anti-infective therapy within 72 hours prior to chemotherapy;
- •Patients with severe mouth ulcers;
- •Participated in 3 or more clinical trials of a drug within the last year, or participated in any clinical trial of a drug within the last 3 months, as a subject and actually used the test drug;
- •Hypersensitivity to the adjuvant or neoadjuvant chemotherapeutic agents used (e.g., docetaxel, epirubicin, carboplatin, cyclophosphamide) and to PEG-G-CSF and G-CSF analogs;
- •Lithium-treated patients were required during the clinical trial;
- •Alcohol-dependent individuals or those with a history of substance abuse;
- •Lactating and pregnant females and those planning a pregnancy within 6 months of the last injection of the test drug in this study;
- •Combined primary diseases of the cerebrovascular, hepatic, renal, endocrine, and hematologic systems of a severity judged by the investigator to be inappropriate for participation in this clinical trial;
- •Other patients who, in the judgment of the investigator, are not suitable subjects for this trial.
研究组 & 干预措施
PEG-G-CSF injection (Kexing Biopharmaceutical Co., Ltd.)
Experimental
A single subcutaneous injection of 6 mg PEG-G-CSF injection (Kexing Biopharmaceutical Co., Ltd.) was administered 24h+2h after the end of chemotherapy administration on day 1 of each chemotherapy cycle; Inject at least 1 cycle of chemotherapy with PEG-G-CSF injection, and up to 4 cycles of chemotherapy.
干预措施: PEG-G-CSF injection (Kexing Biopharmaceutical Co., Ltd.) (Drug)
PEG-G-CSF injection (Neulasta®，Amgen Europe B.V.)
Active Comparator
Single subcutaneous injection of 6 mg PEG-G-CSF injection ( Neulasta®, Amgen Europe B.V.) 24h+2h after the end of chemotherapy administration on day 1 of each chemotherapy cycle in the abdomen (5 cm beyond the umbilicus); Inject at least 1 cycle of chemotherapy with PEG-G-CSF injection, and up to 4 cycles of chemotherapy.
干预措施: PEG-G-CSF injection (Neulasta®，Amgen Europe B.V.) (Drug)
结局指标
主要结局
Duration of 4th degree neutropenia during chemotherapy cycle 1
时间窗: At the end of Cycle 1 (each cycle is 21 days)
次要结局
- Lowest neutrophil count during chemotherapy cycle 1;(At the end of Cycle 1 (each cycle is 21 days))
- Time required for neutrophil count to recover from nadir to above 2.0 × 109/L during chemotherapy cycle 1;(At the end of Cycle 1 (each cycle is 21 days))
- Duration of 4th degree neutropenia during cycles 2, 3, and 4 of chemotherapy;(At the end of cycles 2, 3, and 4 (each cycle is 21 days))
- Incidence of 3rd or 4th degree neutropenia during cycles 1, 2, 3, and 4 of chemotherapy;(At the end of cycles 1, 2, 3, and 4 (each cycle is 21 days))
- Duration of febrile neutropenia (FN) in cycles 1, 2, 3, and 4 of chemotherapy;(At the end of cycles 1, 2, 3, and 4 (each cycle is 21 days))
- Incidence of neutropenic fever (FN) during cycles 1, 2, 3, and 4 of chemotherapy;(At the end of cycles 1, 2, 3, and 4 (each cycle is 21 days))
- Incidence of infection during cycles 1, 2, 3, and 4 of chemotherapy;(At the end of cycles 1, 2, 3, and 4 (each cycle is 21 days))
- Proportion of participants using antibiotics during cycles 1, 2, 3, and 4 of chemotherapy.(At the end of cycles 1, 2, 3, and 4 (each cycle is 21 days))
研究者
研究点 (1)
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