An Open-Label Phase II Study of Capecitabine in Combination With Pegylated Interferon Alfa-2a in Patients With Advanced Hepatocellular Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 16
- 主要终点
- Objective response rate
研究概览
简要总结
This study will evaluate the efficacy and safety of capecitabine (Xeloda) in combination with peginterferon alfa-2a (Pegasys) in participants with advanced liver cancer who have had no prior treatment. The anticipated time on study treatment is until disease progression, and the target sample size is 43 individuals.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 18 to 75 years of age
- •Locally advanced or metastatic liver cancer with measurable disease and not eligible for any standard therapy
排除标准
- •Previous treatment for liver cancer
- •Main portal vein involvement
- •Bone, brain, or leptomeningeal metastasis
- •Clinically significant cardiac disease
- •Malabsorption syndrome or lack of physical integrity of the upper gastrointestinal tract
- •History of other cancer, except basal cell skin cancer or in situ cancer of the cervix
研究组 & 干预措施
Capecitabine + Peginterferon alfa-2a
Treatment-naive participants with advanced liver cancer will receive combination treatment with capecitabine (1000 milligrams per meter-squared [mg/m^2] twice daily orally on Days 1 to 14 of each 21-day cycle) and peginterferon alfa-2a (180 micrograms (mcg) subcutaneous [SC] every week during each 21-day cycle) until at least 6 cycles (18 weeks) or disease progression, intolerable toxicity, or consent withdrawal.
干预措施: Capecitabine (Drug)
Capecitabine + Peginterferon alfa-2a
Treatment-naive participants with advanced liver cancer will receive combination treatment with capecitabine (1000 milligrams per meter-squared [mg/m^2] twice daily orally on Days 1 to 14 of each 21-day cycle) and peginterferon alfa-2a (180 micrograms (mcg) subcutaneous [SC] every week during each 21-day cycle) until at least 6 cycles (18 weeks) or disease progression, intolerable toxicity, or consent withdrawal.
干预措施: Peginterferon alfa-2a (Drug)
结局指标
主要结局
Objective response rate
时间窗: up to post-chemotherapy follow-up ( approximately 46 months)
次要结局
- Duration of response(Up to approximately 46 months)
- Time to disease progression(Up to approximately 46 months)
- Overall survival(Up to approximately 46 months)
- Incidence of adverse events(Up to approximately 46 months)