NCT00635323已完成2 期
A Phase 2 Study of the Efficacy and Safety of Irinotecan (Campto®) in Combination With Capecitabine (Xeloda®) as First-Line Chemotherapy in Asian Subjects With Inoperable 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
- 发起方
- Pfizer
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Overall response rate
研究概览
简要总结
To evaluate the safety and efficacy of irinotecan and capecitabine in Asian subjects with inoperable 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Asian subjects with histologically or cytologically confirmed hepatocellular carcinoma
- •Inoperable disease (unable to completely remove surgically, presence of extra-hepatic disease, main portal vein or hepatic vein involvement)
- •Eastern Cooperative Oncology Group performance status of ?2
排除标准
- •Decompensated cirrhosis or stage C (Index>10) according to the Child-Pugh Classification
- •Current history of chronic diarrhoea
- •Reproductive potential not using adequate contraceptive measures
研究组 & 干预措施
A
Experimental
干预措施: Irinotecan plus capecitabine (Drug)
结局指标
主要结局
Overall response rate
时间窗: Week 6
次要结局
- Time to progression(Weeks 6, 12, 18, 24, 36, and 1 year)
- Duration of overall response(Weeks 6, 12, 18, 24, 36, and 1 year)
- Overall tumour growth control rate(Weeks 6, 12, 18, 24, 36, and 1 year)
- Overall survival(Weeks 6, 12, 18, 24, 36, and 1 year)
- Adverse events(Weeks 6, 12, 18, 24, 36, and 1 year)
- Physical exam(Weeks 6, 12, 18, 24, 36, and 1 year)
- Laboratory tests(Weeks 6, 12, 18, 24, 36, and 1 year)
研究者
研究点 (1)
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