An Open-label, Multicentre Phase IV Study of Trastuzumab in Combination With the Standard Therapy (as Per Routine Clinical Practice) as First-line Therapy in Patients With HER2 Positive Metastatic Gastric Cancer
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 4
- 主要终点
- Median Progression Free Survival (PFS)
研究概览
简要总结
This open-label, multi-center study will evaluate the efficacy and safety of Herceptin (trastuzumab) in combination with standard chemotherapy as first-line treatment in patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-esophageal junction. Patients will receive standard chemotherapy for a maximum of 6 cycles, and 8 mg/kg Herceptin as loading dose on day 1, followed by 6 mg/kg intravenous infusion every 3 weeks until disease progression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Histologically confirmed adenocarcinoma of the stomach or gastro-esophageal junction with advanced or metastatic disease, not amenable to curative therapy
- •Measurable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST)
- •HER2 positive tumor (primary tumor or metastasis
- •ECOG Performance status 0, 1 or 2
- •Life expectancy of at least 3 months
排除标准
- •Previous chemotherapy for advanced or metastatic disease less than 6 month before study start
- •Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome (patients with partial or total gastrectomy are allowed to participate in the study)
- •Patients with active (significant or uncontrolled) gastrointestinal bleeding
- •Residual relevant toxicity resulting from previous chemotherapy
- •Other malignancy within the last 5 years (except carcinoma in situ of the cervix, or basal cell carcinoma)
研究组 & 干预措施
1
干预措施: trastuzumab [Herceptin] (Drug)
结局指标
主要结局
Median Progression Free Survival (PFS)
时间窗: Baseline up to PD or death (maximum up to 22 months)
The PFS was defined as the median time between the day of enrollment and the first documentation of progressive disease (PD) or date of death, whichever occurred first. PD was defined as at least 20 percent (%) increase (including an absolute increase of at least 5 millimeters \[mm\]) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. The censoring date was the last date of "last tumor measurement," "last date of study drug treatment," or "last follow-up." The median PFS time with 95% confidence interval (CI) was estimated using Kaplan Meier method.
次要结局
- Percentage of Participants With Overall Tumor Response(Baseline up to PD or death (maximum up to 22 months))
- Percentage of Participants With Clinical Benefit Response (CBR)(Baseline up to PD or death (maximum up to 22 months))
- Number of Participants With Human Epidermal Growth Factor Receptor 2 (HER2) Positive Gastric Cancer(Baseline)
- Overall Survival (OS)(Baseline up to death (maximum up to 22 months))
- Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)(Baseline up to 6 month after last dose of study drug (maximum up to 22 months))
- Number of Participants With Clinically Significant Change From Baseline in Left Ventricular Ejection Fraction (LVEF)(Baseline, thereafter every 12 weeks (maximum up to 22 months))
- Duration of Response (DR)(Baseline up to PD or death (maximum up to 22 months))
- Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters(Baseline up to 6 month after last dose of study drug (maximum up to 22 months))