NCT00524498已完成2 期
A Phase II Study of a Continuous Hepatic Arterial Infusion Combination Therapy With OPC-18 and 5-FU in Patients With Highly Advanced Hepatocellular Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Antitumor effect (tumor size reduction)
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of a continuous hepatic arterial infusion combination therapy with OPC-18 and 5-FU versus BST in patients with highly advanced hepatocellular carcinoma for which resection therapy or local therapy is inapplicable due to advanced vascular invasion.
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
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are histologically or clinically (diagnostic imaging and tumor marker) diagnosed with hepatocellular carcinoma
- •Patients with a measurable lesion by contrast CT
- •Patients with no remote metastasis (extrahepatic metastasis), confirmed by X-ray, CT, MRI, or other means if necessary
- •Patients who have not previously received intra-arterial hepatic chemotherapy
排除标准
- •Patients receiving the herbal medicine shosaikoto
- •Patients with autoimmune hepatitis
- •Patients with a history of hypersensitivity to OPC-18 or other interferon preparations
研究组 & 干预措施
A
Experimental
FAIT
干预措施: OPC-18 (Drug)
B
Active Comparator
BST
干预措施: cisplatin (Drug)
结局指标
主要结局
Antitumor effect (tumor size reduction)
时间窗: every 4 weeks
次要结局
- Disease control rate Overall survival Progression-free survival(every 4 weeks)
研究者
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