NCT01008358已完成2 期
Phase II Trial of Anti-CTLA-4 Human Monoclonal Antibody CP-675,206 in Patients With Advanced Hepatocellular Carcinoma
Clinica Universidad de Navarra, Universidad de Navarra3 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2008年12月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- Tumor response by Response Evaluation Criteria In Solid Tumors (RECIST)
研究概览
简要总结
CP-675,206 (tremelimumab) is a fully humanized monoclonal antibody that binds to activated T lymphocytes and by enhancing their activation may produce a stimulation of the immune response against tumoral or viral antigens. In this clinical trial, the ability of tremelimumab to produce tumor responses among hepatitis C virus-infected patients with hepatocellular carcinoma not amenable to other therapies will be explored. Besides, the effect on the replication of the virus will be analysed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Unequivocal diagnosis of HCC
- •unresectable disease not amenable to locoregional treatment.
- •a 4-week washout period after sorafenib or any other systemic agent
- •a 2-month washout period after internal or external radiation
- •HCV chronic infection
- •Child-Pugh stage A or B
- •Measurable disease according to RECIST criteria
- •ECOG < 2
- •expected survival > 3 months
- •Adequate liver, renal and blood functions
- •ability to sign informed consent
排除标准
- •previous treatment with an anti-CTL-4 agent
- •serious infections or disease compromising general health status
- •autoimmune disease that requires therapy
- •treatment with immunosuppressors
- •treatment with investigational agents
- •other neoplasms except skin and bladder superficial tumors
- •pregnancy or lactation
- •SNC metastasis
- •HIV infection
- •relevant heart disease (NYHA class III or IV)
结局指标
主要结局
Tumor response by Response Evaluation Criteria In Solid Tumors (RECIST)
次要结局
- Changes in Hepatitis C Virus (HCV) viral load
研究者
研究点 (3)
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