NCT02226289Unknown2 期
Phase II Study of Bevacizumab-containing Regimen in Patients With Metastatic Colorectal Cancer Who Failed to Cytotoxic Treatment
Sixth Affiliated Hospital, Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2020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
- 46
- 试验地点
- 1
- 主要终点
- Response rate
研究概览
简要总结
Bevacizumab, a humanized monoclonal antibody against vascular endothelial growth factor (VEGF), combined with fluoropyrimidine-based chemotherapy is now the standard first and second-line treatment for metastatic colorectal cancer. The efficacy of bevacizumab with cytotoxic agents in the third-line treatment of patients with mCRC is still unknown.
详细描述
This is a single arm, phase II, open-labelled clinical trial to evaluate the safety and efficacy of bevacizumab combined with cytotoxic agents in the treatment of patients with mCRC progressing under all available cytotoxic 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent obtained.
- •Subjects must be able to understand and willing to sign a written informed consent.
- •Subjects > 18 years of age
- •Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Histological or cytological diagnosis of adenocarcinoma of the colon or rectum.
- •Subjects have unresectable metastatic lesions.
- •Subjects failed to respond to oxaliplatin, irinotecan and fluorouracil.
- •Subjects have at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria measured within 4 weeks prior to registration.
- •Leukocytes ≥ 3.0 x109/ L, absolute neutrophil count (ANC) ≥ 1.5 x109/ L, platelet count ≥ 100 x109/ L, hemoglobin (Hb) ≥ 9g/ dL.
- •Total bilirubin ≤1.5 x the upper limit of normal (ULN).
- •Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 x ULN.
- •Amylase and lipase ≤ 1.5 x the ULN.
- •Serum creatinine ≤ 1.5 x the ULN.
- •Calculated creatinine clearance or 24 hour creatinine clearance ≥ 50 mL/ min.
排除标准
- •Any previous or concurrent cancer that is distinct in primary site or histology from colorectal cancer within 5 years prior to this study.
- •Extended field radiotherapy within 4 weeks or limited field radiotherapy within 2 weeks prior to randomization.
- •Major surgical procedure, open biopsy, or significant traumatic injury within 4 weeks before start of study medication.
- •Uncontrolled hypertension. (systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg despite optimal medical management).
- •Significant cardiovascular disease including unstable angina or myocardial infarction within 6 months before initiating study treatment or a history of ventricular arrhythmia
- •Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within the 6 months before start of study medication.
- •Any evidence of active infection.
- •Known history of human immunodeficiency virus (HIV) infection.
- •History of bleeding diathesis or coagulopathy.
- •History of interstitial pneumonitis or pulmonary fibrosis
- •Pregnancy or lactation at the time of study entry.
- •Any history of or currently known brain metastases.
- •Known dihydropyrimidine dehydrogenase (DPD) deficiency
- •Any illness or medical conditions that are unstable or could jeopardize the safety of the subjects and his/her compliance in the study.
- •Subjects with known allergy to the study drugs or to any of its excipients.
- •Current or recent (within 4 weeks prior to starting study treatment) treatment of another investigational drug or participation in another investigational study.
研究组 & 干预措施
bevacizumab-containing
Experimental
bevacizumab with the latest received cytotoxic regimen
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Response rate
时间窗: Baseline and 6 weeks
Percentage of tumor regression
次要结局
- Overall survival(From date of treatment until the date of death of any cause, assessed up to 48 months)
- Progression free survival(From date of treatment until the date of disease progression, assessed up to 48 months)
研究者
Jian Xiao
Associate Professor
Sixth Affiliated Hospital, Sun Yat-sen University
研究点 (1)
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