NCT01763450Unknown2 期
LIAONING CANCER HOSPITAL&INSTITUTE
Liaoning Tumor Hospital & Institute2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2012年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- To assess the objective response rate(ORR)
研究概览
简要总结
A multi-center, non-random, open study ,to observe efficacy and safety of bevacizumab plus Oxaliplatin based multidrug chemotherapy as conversion therapy for patients with previously untreated unresectable liver metastases from colorectal cancer.
详细描述
PRIMARY OBJECTIVES：To assess the objective response rate(ORR)（8 weeks after chemotherapy）
SECONDARY OBJECTIVES：
- To assess the R0 resection rate of liver metastases（8 weeks after chemotherapy、every three months follow-up 1 time in R0 postoperative 1-2 years、Every six months follow-up 1 time in R0 postoperative 2-5 years）
- To assess the incidence of adverse events of level 3-4 （Bleeding、Gastrointestinal Perforation、Anastomotic Fistula、Hypertension、Wound Healing Delay）（8 weeks after chemotherapy）
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written inform consent form
- •histologically or cytologically confirmed Colorectal Adenocarcinoma
- •Age≥18 and ≤80 years old
- •Primary colorectal cancer and liver metastases，Liver lesions determined to be unresectable by multidisciplinary team (MDT) （primary lesions surgically removed）
- •Simultaneity or heterochrony metastases
- •Colorectal cancer lesions from anal edge at least 8 cm
- •Within 6 months did not receive any chemotherapy, including targeted therapy
- •One or more measurable lesions, conventional Computed Tomography(CT) scanning measurement diameter at least 20 mm [Response Evaluation Criteria In Solid Tumors(RECIST) standard]
- •Eastern Collaborative Oncology Group(ECOG) 0 or 1
- •Expected lifetime at least for 12 weeks
- •Screening within 7 days， the ability of bone marrow, liver and kidney function reserve enough；Absolute neutrophil count（ANC）≥1.5x109/L; hemoglobin≥9.0g/dl; platelet count≥80 x109/L; Total Bilirubin(TBil)≤1.5 x upper level of normal range(ULN); Alanine Aminotransferase(ALT) and Aspartate Aminotransferase(AST)≤2.5 x ULN(Patients with hepatic metastasis≤5x ULN); alkaline phosphatase≤4 x ULN; serum creatinine≤1.5 x ULN;
- •Women of reproductive age should take effective contraceptive measures;
排除标准
- •Arrhythmia requiring medication（except β- receptor blocking pharmacon and digoxigenin），symptomatic coronary artery disease and myocardial ischemia [myocardial infarction (≤6months before enrollment)]，congestive heart failure [≥New York Heart Association(NYHA)2];
- •History of HIV infection,Chronic hepatitis B or hepatitis C of active phase(high copy virus DNA);
- •Other activated serious infection [>National Cancer Institute-Common Toxicity Criteria(NCI-CTC) 3.0];
- •Any extrahepatic metastases;
- •Seizures requiring medication(such as steroids or antiepileptic therapy);
- •Other malignancies in the past 5 years (except curatively treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix);
- •Chronic inflammatory bowel disease, intestinal obstruction;
- •Drug abuse and medicine, psychology or social conditions may interfere with patients to participate in research or the results of the evaluation have influence;
- •Known or suspected allergy to any investigational drug in this study;
- •Any unstable condition or is likely to endanger the patient safety and compliance situation;
- •Pregnant or lactating women not using or refusing to use effective non hormonal means of contraception;
研究组 & 干预措施
Bevacizumab plus chemotherapy
Experimental
- Bevacizumab:
7.5mg/kg, iv, on day 1 of each 21 day cycle or 5mg/kg, iv, on day 1 of each 14 day cycle; 2. Oxaliplatin+capecitabine(XELOX):( The total dose not less than 70% of the recommended dose of this standard) Oxaliplatin: 130mg/m2,d1; capecitabine: 850-1,000mg/m2，d1-d14, bid，each 21 day cycle; 3. Oxaliplatin+5-Fluorouracil+ Levomisole（FOLFOX）:
Oxaliplatin: 85mg/m2,iv for 2 hours ,d1; Levomisole（LV）: 400mg/m2,iv for 2 hours,d1; 5-Fluorouracil（5-FU） :400mg/m2 iv,d1,then 1200mg/m2/d ×2d continuous intravenous infusion(volume dose:2400mg/m2,iv for 46-48 hours ) each 14 day cycle;
干预措施: bevacizumab plus chemotherapy (Drug)
结局指标
主要结局
To assess the objective response rate(ORR)
时间窗: 8 weeks after chemotherapy
次要结局
- To assess the R0 resection rate of liver metastases(8 weeks after chemotherapy、every three months follow-up 1 time in R0 postoperative 1-2 years、Every six months follow-up 1 time in R0 postoperative 2-5 years)
研究者
Chun Song
Professor
Liaoning Tumor Hospital & Institute
研究点 (2)
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