A Randomized, Controlled, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of Sheng Bai Oral Liquid in Prevention and Treatment for The Decrease of Neutrophils After Chemotherapy in Patients With Non-Small-Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- The incidence and degree of neutropenia after chemotherapy
研究概览
简要总结
The purpose of the study is to evaluate the efficacy and safety of Sheng Bai oral liquid in prevention and treatment of the decrease of neutrophilics after chemotherapy in patients with non-small-cell lung cancer.
详细描述
The Clinical trail is a multicenter, prospective, randomized controlled study. The planned sample size is 240 subjects. These subjects will be randomized (1:1) to treatment group (Platinum-based two medicine (carboplatin / cisplatin) plus Sheng Bai oral liquid) or control group ( Platinum-based two medicine (carboplatin / cisplatin) plus blank control). The study population includes the patients with non-small-cell lung cancer .
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are confirmed no small cell lung cancer in accordance with the clinical diagnostic criteria , or by pathological histology or cytology examination which investigators think are suitable to accept The platinum-based doublet chemotherapy（According to RECIST V1.1,patients with no small cell cancers should have one measurable lesions at least ）.
- •ECOG performance status ≤
- •Laboratory inspection basically meets the following requirements： 1)Blood test：a. WBC≥ 4.0×109/L, b. ANC≥2.0×109/L, c. PLT≥100×109/L. 2)Biochemical test：a. ALT≤2.5 times the ULN;b. AST≤2.5 times the ULN ;c. Cr<=1.5 times the ULN.
- •Expected survival period is more than 3 months
- •Subjects join the study voluntarily, sign a consent form, have good compliance, and comply with follow-up.
排除标准
- •Patients need radiotherapy, targeted therapy, and other anti-cancer therapies during the trial.
- •Patients accepted radiation in the past 4 weeks before enrollment.
- •Previous bone marrow or stem cell transplant, or organ allograft.
- •Recently severe acute infection is not controlled; purulent or chronic infection is present and the wound is not healed.
- •Patients were or being suspected to be allergic to test drugs or related components.
- •Patients with hypersplenism, hyperthyroidism, adrenal cortical hypofunction, connective tissue disease, infectious diseases, such as viral hepatitis, tuberculosis infection and other diseases which can lead to the decrease of the white blood cells at the same time.
- •Patients with the symptoms of digestive system, such as nausea, vomiting, diarrhea, etc., that are not controlled will influence the test drug.
- •The central nervous system is metastatic and has symptoms.
- •History of another malignancy, except for in situ carcinoma of the cervix, adequately treated basal cell skin carcinoma.
- •Patients with severe heart, liver and kidney diseases; serious diseases of hematopoietic system; bleeding tendency.
- •Patients have a history of drug abuse and cannot be reined ;Patients with symptomatic, uncontrolled nervous disorders, mental illness or psychiatric disorder have less compliance.
- •Female patient is pregnant or breast-feeding, and those patients at childbearing age who are not willing to use methods of contraception.
- •Patients who are currently included in other clinical trials or accepted any experimental drugs in the past 4 weeks.
- •Any condition, in the investigator's opinion, is not in the best interest of the subject.
研究组 & 干预措施
Treatment group
Platinum-based two medicine (carboplatin / cisplatin) plus Sheng Bai oral liquid.
干预措施: Sheng Bai oral liquid (Drug)
Treatment group
Platinum-based two medicine (carboplatin / cisplatin) plus Sheng Bai oral liquid.
干预措施: Platinum-based two medicine (carboplatin / cisplatin) . (Drug)
Control group
Blank control and Platinum-based two medicine (carboplatin / cisplatin) .
干预措施: Platinum-based two medicine (carboplatin / cisplatin) . (Drug)
结局指标
主要结局
The incidence and degree of neutropenia after chemotherapy
时间窗: six weeks
Comparison of the incidence and extent of neutrophil reduction in two chemotherapy cycles between two groupschemotherapy cycles between two groups according to CTC AE4.03,as well as the recovery time of neutropenia
The recovery time of neutropenia
时间窗: six weeks
Comparison of the recovery time between two groups of Polymorphonuclear neutropenia
次要结局
- The duration of Peripheral blood thrombocytopenia disease(six weeks)
- THE incidence and duration of peripheral blood leukocyte reduction(six weeks)
- The duration of peripheral blood leukocyte reduction(six weeks)
- Neutrophil value of neutrophils in patients with low to lowest level after chemotherapy(six weeks)
- The incidence of neutropenia associated with Fever (FN) in patients after chemotherapy(six weeks)
- The incidence of Peripheral blood thrombocytopenia disease(six weeks)
- THE incidence and duration of hemoglobin reduction in peripheral blood(six weeks)
- THE duration of hemoglobin reduction in peripheral blood(six weeks)
- The time when the neutrophils were reduced to the lowest point after chemotherapy(six weeks)
- Cancer-related fatigue(six weeks)
- Immune Index (optional)(six weeks)
- MDASI-TCM(six weeks)
- rhG-CSF dosage(six weeks)