Effect of Intravenous Pump of Recombinant Human Endostatin Combined With XELOX Chemotherapy, and a Potential Prognostic Biomarkers in Patient With Advanced Colorectal Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Progression free survival
研究概览
简要总结
To study safety and efficacy of intravenous pump of recombinant human endostatin combined with XELOX-treated and also investigate the potential value of CECs level for the prediction of PD and outcomes in patients with advanced colorectal 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
- Triple (Participant, Care Provider, Investigator)
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
- •Clear pathology diagnosis of stage for the Ⅳ period of advanced colorectal cancer.
- •There are at least 1 imaging examinations according to the standard of RECIST（the longest diameter is at least 10mm with spiral CT and 20mm with ordinary CT）.
- •Male or female , age 18～75
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •The patients had to have a life expectancy of at least 3 months.
- •A white blood count (WBC) greater than 3000/mm3, platelets greater than 100 000/mm3, and normal coagulation values.
- •Aspartate aminotransferase (AST) and adenosine triphosphate (ALT) values were to be less than 2.5 times the upper limit of normal;a bilirubin level of less than 25 lmol/l；a creatinine value less than 130 lmol/l.
- •Informed consent was obtained from all patients.
排除标准
- •Patients having a brain tumor or brain metastases, a bleeding disorder, receiving anti-coagulant therapy.
- •a history of myocardial infarction or angina pectoris in the last 6 months or uncontrolled congestive heart failure, having an active infection or receiving radio- or chemotherapy within 4 weeks before study.
- •patients with uncontrolled serious medical or psychiatric illness or having any other condition that was likely to interfere with regular follow-up.
研究组 & 干预措施
XELOX chemotherapy with recombinant human endotatin
Patients received a triweekly treatment cycle.Oxaliplatin(130mg/m2 over 2h)was intravenously administated for at least 2h on day 1. Capecitabine(1000mg/m2 twice daily)was oral administrated from the evening of day 1 to the morning of day 15.The dose of Recombinant human endostatin on day -5 was calculated according to the patients's body surface area, to provide a CIV 7 days' dose in physiological saline to 240mL volume.
干预措施: oxaliplatin + capecitabine (XELOX chemotherapy) (Drug)
XELOX chemotherapy with recombinant human endotatin
Patients received a triweekly treatment cycle.Oxaliplatin(130mg/m2 over 2h)was intravenously administated for at least 2h on day 1. Capecitabine(1000mg/m2 twice daily)was oral administrated from the evening of day 1 to the morning of day 15.The dose of Recombinant human endostatin on day -5 was calculated according to the patients's body surface area, to provide a CIV 7 days' dose in physiological saline to 240mL volume.
干预措施: rebombniant human endostatin (Drug)
XELOX chemotherapy without recombinant human endotatin
Patients received a triweekly treatment cycle.Oxaliplatin(130mg/m2 over 2h)was intravenously administated for at least 2h on day 1. Capecitabine(1000mg/m2 twice daily)was oral administrated from the evening of day 1 to the morning of day 15.
干预措施: oxaliplatin + capecitabine (XELOX chemotherapy) (Drug)
结局指标
主要结局
Progression free survival
时间窗: 4 years
Evaluate the effect of XELOX therapy with or without recombinant human endostatin on progression free survival
次要结局
- Overall survival(4 years)
- local control(4 years)
研究者
ming zeng, MD
Director of Cancer Center
Sichuan Provincial People's Hospital