NCT00966251终止1 期
Phase I/II Safety and Tolerability Study of the Monoclonal Antibody CT-011 in Patients With Hepatocellular Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- CureTech Ltd
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- To assess the safety and tolerability of CT-011 in patients with Primary Hepatocellular Carcinoma
研究概览
简要总结
The objective of this pilot study is to evaluate the safety, tolerability and activity of the monoclonal antibody CT-011 administered intravenously to patients with Primary Hepatocellular Carcinoma.
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
- •Subjects aged 18 years and above, both genders.
- •Histologically or cytologically confirmed Primary Hepatocellular Carcinoma (HCC)
- •No fibrolamellar subtype HCC
- •Not eligible for any other systemic anti-neoplastic treatment approved for HCC
- •Not eligible for Transarterial chemoembolization (TACE ).
- •No more than 1 prior systemic therapy. Previous TACE or Radiofrequency ablation (RFA) that were used for HCC, are permitted.
- •Not a candidate for curative surgical resection or liver transplantation
- •Measurable disease defined by the identification at least 1 measurable lesion by MRI using RECIST criteria. Tumor in area of TACE or RFA must be enlarging post-procedure to be considered measurable disease.
- •Alpha-fetoprotein (AFP) greater than the upper limit of normal (ULN)
- •Child's Pugh classification A
- •ECOG performance status 0-1
排除标准
- •Patients progressing to liver failure.
- •No core biopsy within the past 7 days
- •Patients who are eligible for Transarterial Chemoembolization (TACE)
- •Patients on concurrent anti-neoplastic therapy (including interferon)
- •Patients who have received any systemic anti-neoplastic therapy not approved for the treatment of HCC.
- •Patients on concurrent steroids, other than those allowed for routine antiemetics, or inhaled steroids
- •Presence of metastasis.
研究组 & 干预措施
CT-011
Experimental
干预措施: CT-011 (Drug)
结局指标
主要结局
To assess the safety and tolerability of CT-011 in patients with Primary Hepatocellular Carcinoma
时间窗: 12 months
次要结局
未报告次要终点
研究者
研究点 (1)
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