Study of Endostar Combined With mFOLFOX6 for First-line Treatment of Metastatic Colorectal Cancer and Efficacy Prediction
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
This study is to assess the efficacy and safety of Endostar combined with mFOLFOX6 in untreated metastatic colorectal cancer patients, and to find the markers that may predict the efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Histologically or cytologically confirmed metastatic colorectal cancer (adenocarcinoma)
- •At least one measurable lesion (RECIST criteria)
- •Life expectancy ≥ 3 months
- •ECOG performance status 0-2
- •Adequate hematologic function: ANC ≥ 1.5×109 /L，Hb ≥ 90 g/L，PLT ≥ 100×109 /L
- •Adequate renal function: Cr ≤ 1.25×ULN or Creatinine clearance ≥ 60 ml/min
- •Adequate hepatic function: BIL ≤ 1.5×ULN, ALT/AST ≤ 2.5×ULN, Alkaline phosphatase ≤ 5×ULN
- •Patients have not previously received palliative chemotherapy, immunological/ biological treatment
- •No adjuvant chemotherapy in last six months
- •Target lesion has not received local radiotherapy
- •Written informed consent
排除标准
- •Diagnosis of colorectal neuroendocrine tumor, undifferentiated carcinoma, adenosquamous carcinoma, squamous cell carcinoma
- •Evidence of serious or uncontrolled infection
- •Serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia, unstable angina, myocardial infarction, serious heart valve disease, resistant hypertension)
- •Pregnant or lactating women
- •Women of childbearing potential refused to practice acceptable methods of birth control to prevent pregnancy
- •Allergic to any of the study drug
- •Intestinal obstruction, intestinal perforation, or stroke within 3 months
- •Participation in other clinical studies
研究组 & 干预措施
Treatment
Endostar d1-d7 15mg/d Oxaliplatin 85 mg/m2 d6 Folinic acid 400 mg/m2 d6 5-FU 400 mg/m2 d6, and then 5-FU 2,400 mg/m2 INTRAVENOUS over 46 h
干预措施: Folinic acid (Drug)
Treatment
Endostar d1-d7 15mg/d Oxaliplatin 85 mg/m2 d6 Folinic acid 400 mg/m2 d6 5-FU 400 mg/m2 d6, and then 5-FU 2,400 mg/m2 INTRAVENOUS over 46 h
干预措施: 5-FU (Drug)
Treatment
Endostar d1-d7 15mg/d Oxaliplatin 85 mg/m2 d6 Folinic acid 400 mg/m2 d6 5-FU 400 mg/m2 d6, and then 5-FU 2,400 mg/m2 INTRAVENOUS over 46 h
干预措施: Endostar (Drug)
Treatment
Endostar d1-d7 15mg/d Oxaliplatin 85 mg/m2 d6 Folinic acid 400 mg/m2 d6 5-FU 400 mg/m2 d6, and then 5-FU 2,400 mg/m2 INTRAVENOUS over 46 h
干预措施: Oxaliplatin (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: the end of the 3rd cycle
次要结局
- Blood perfusion in tumor tissue(baseline, the end of the 3rd cycle)
- Ratio of blood perfusion in tumor tissue to blood perfusion in surrounding normal tissue(baseline, the end of the 3rd cycle)
- Incidence of Adverse Events(up to 1 month after the last cycle)