A Single-arm, Open-label Study of Avastin Plus Xeloda on Objective Treatment Response in Patients With Advanced or Metastatic Liver Cancer Who Have Had no Previous Cytotoxic Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 45
- 主要终点
- Percentage of Participants With Objective Response (OR)
研究概览
简要总结
This study will evaluate the efficacy and safety of oral Xeloda (capecitabine) plus intravenous Avastin (bevacizumab) in patients with advanced or metastatic liver cancer. The anticipated time on study treatment is 3-12 months.
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
- •adult patients >=18 years of age;
- •advanced or metastatic liver cancer;
- •>=1 measurable lesion.
排除标准
- •current radiotherapy, chemotherapy, or other experimental therapies;
- •prior cytotoxic chemotherapy;
- •major surgery, open biopsy, or traumatic injury within 28 days of study entry;
- •history of a malignancy during the last 5 years, other than cutaneous basal cell cancer or in situ cervical cancer.
研究组 & 干预措施
Avastin + Xeloda
干预措施: bevacizumab [Avastin] (Drug)
Avastin + Xeloda
干预措施: capecitabine [Xeloda] (Drug)
结局指标
主要结局
Percentage of Participants With Objective Response (OR)
时间窗: Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up
Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. The best overall response achieved within the time from first drug administration to progressive disease or end of study was reported. CR was defined as complete disappearance of all target lesions and non-target disease, with the normalization of tumor marker levels. No new lesions. PR was defined as greater than or equal to (≥) 30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target lesions. Persistence of one or more non-target lesion(s) or/and maintenance of tumor marker levels above the normal limits. No new lesions.
次要结局
- Time to Disease Progression(Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up)
- Overall Survival - Percentage of Participants With an Event(Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.)
- Overall Survival(Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.)
- Overall Survival - Percentage of Participants Event Free at 12 Months(Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.)
- Percentage of Participants With Disease Control(Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up)
- Time to Disease Progression - Percentage of Participants With an Event(Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up)
- Time to Disease Progression - Percentage of Participants Progression-free at 12 Months(Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.)