NCT00565370已完成1 期
A Phase I-II Study of Sorafenib (Nexavar®) in Combination With Capecitabine and Cisplatin (XP) in Patients With Advanced Gastric Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Number of Participants Who Experienced Dose Limiting Toxicities (DLTs)
研究概览
简要总结
There is strong scientific rationale for exploring the role of sorafenib with capecitabine and cisplatin (XP) in AGC. XP is a new standard of care in AGC and sorafenib is a novel signal transduction inhibitor that prevents tumor cell proliferation and angiogenesis through blockade of the Raf/MEK/ERK pathway at the level of Raf kinase and the receptor tyrosine kinases VEGF-R2 and PDGFR-beta.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Having given signed written informed consent
- •Unresectable advanced gastric adenocarcinoma, initially diagnosed or recurred
- •No history of chemotherapy or radiation
- •Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST)
- •Age 18-75 years
- •Estimated life expectancy of more than 3 months
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •Adequate bone marrow function (absolute neutrophil count > 1,500/µL, platelets > 100,000/µL, hemoglobin > 8g/dl),
- •Adequate kidney function (creatinine clearance > 60 ml/min)
- •Adequate liver function (bilirubin < 2.0 mg/dL, transaminases levels < 3 times the upper normal limit [5 times for patients with liver metastasis])
排除标准
- •Past or concurrent history of neoplasm other than gastric adenocarcinoma, except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix uteri
- •Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start
- •Presence of central nervous system metastasis
- •Obvious peritoneal seeding or bowel obstruction
- •Evidence of serious gastrointestinal bleeding
- •Peripheral neuropathy (National Cancer Institute Common Terminology Criteria for Adverse Event version 3.0 > Grade I)
- •History of significant neurologic or psychiatric disorders
- •Pregnant or lactating women, women of childbearing potential not employing adequate contraception
- •Other serious illness or medical conditions
- •Known allergy to study drugs
研究组 & 干预措施
B
Placebo Comparator
XP
干预措施: Capecitabine, Cisplatin, Sorafenib (Drug)
A
Experimental
XP+sorafenib
干预措施: Capecitabine, Cisplatin, Sorafenib (Drug)
结局指标
主要结局
Number of Participants Who Experienced Dose Limiting Toxicities (DLTs)
时间窗: 28weeks
Number of Participants who Experienced Dose Limiting Toxicities (DLTs)
Progression-free Survival
时间窗: 1 year
次要结局
- Response Rate(6 months)
- Toxicity Profile (According to National Cancer Institute Common Terminology Criteria for Adverse Event Version 3.0)(28weeks)
- Overall Survival(28 months)
研究者
Yoon-Koo Kang
Professor
Asan Medical Center
研究点 (1)
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