The Comparative Study on Rh-Endostatin (Endostar®) Continuous Intravenous Infusion and Routine i.v in Combination With GP Regimens for Phase III B/IV Squamous Cell Lung Cancer and Biological Markers Exploration.
试验速览
- 阶段
- 3 期
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- objective response rate based on Recist 1.1 edition
研究概览
简要总结
Endostar is a anti-angiogenesis product and has been launched in China . The efficacy and safety have been defined. However, the compliance is unsatisfactory since routine i.v of Endostar is needed for 3 to 4 hours daily during one cycle of 14 days. The continuous intravenous infusion by using venous pump can improve the compliance.The comparative study in efficacy and safety has not been done concerning continuous and routine i.v.In addition, what patient can be benefited from Endostar have not been investigated. The biological markers, such as circulating endothelial cells，CECs, will be explored in the study.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •primary lung squamous carcinoma confirmed by cytology and histology, excluding sputum examination.
- •phase IIIB /IV based on IASLC 2009 TNM criteria.
- •at least one measurable tumor based on RECIST 1.1 ( longest diameter: ≥20 mm by CT scan or 10 mm by spiral CT )
- •male or female, age≥18 or ≤75 years old
- •ECOG PS: 0 or 1
- •estimated time of survival: ≥ 3 months
- •suitable hematologic function: ANC≥2×109/L, PLC≥100×109/L and Hb≥9 g/dL
- •suitable liver function: Total bilirubin≤normal ULN, AST and ALT≤2.5×normal ULN, ALP≤5×normal ULN.
- •suitable renal function: Cr≤normal ULN,or Ccr≥60 ml/min
- •without no healing wound
- •no history of anti-cancer therapy, or adjuvant/neo-adjuvant chemotherapy for non-metastatic tumor finished for more than 6 months before enrolment.
- •for the female subject with productive ability, urine pregnancy test must be done and is negative within 7 days before enrolment.
- •no history of serious allergic to biologic agents, especially E.Coli products
- •the authorized ICF must be signed
排除标准
- •Woman in pregnancy and breast-feeding, or having productive ability without contraception.
- •Having the serious acute infection uncontrolled or purulent/chronic infection with unhealed wound.
- •Having the serious heart disease, including congestive heart failure, uncontrolled high-risk arrhythmia, unstable angina, myocardial infarction, valvular disease, and refractory hypertension.
- •Having uncontrolled nervous or mental disease with low compliance and reluctance to description of response; uncontrolled primary brain tumor or other metastatic brain cancer with obvious intracranial hypertension or mental symptoms.
- •Having the tendency of bleeding, such as FIB<2G/L
- •Being receiving adjuvant chemotherapy.
- •On other conditions investigator considers, the subject is not fitful to participate the trial.
研究组 & 干预措施
Endostar continuous intravenous infusion
Endostar continuous intravenous infusion in combination with Gemcitabine and Cisplatin
干预措施: Endostar continuous intravenous infusion (Drug)
Endostar continuous intravenous infusion
Endostar continuous intravenous infusion in combination with Gemcitabine and Cisplatin
干预措施: Gemcitabine (Drug)
Endostar continuous intravenous infusion
Endostar continuous intravenous infusion in combination with Gemcitabine and Cisplatin
干预措施: Cisplatin (Drug)
Endostar routine intravenous infusion
Endostar routine intravenous infusion in combination with Gemcitabine and Cisplatin
干预措施: Endostar routine intravenous infusion (Drug)
Endostar routine intravenous infusion
Endostar routine intravenous infusion in combination with Gemcitabine and Cisplatin
干预措施: Gemcitabine (Drug)
Endostar routine intravenous infusion
Endostar routine intravenous infusion in combination with Gemcitabine and Cisplatin
干预措施: Cisplatin (Drug)
结局指标
主要结局
objective response rate based on Recist 1.1 edition
时间窗: 3 months
progress free survival
时间窗: 18 months
次要结局
- overall survival(24 months)
- Quality of life (QoL) Questionnaire(24 months)