NCT00568529暂停2 期
Phase II Study on Combination of Capecitabine and Oxaliplatin in Patients With Relapsed or Refractory Gastric Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Response Rate
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and overall survival of the regimen of XELOX (Xeloda and oxaliplatin combination) in the patients with relapsed and refractory gastric cancer.
详细描述
The result of treatment in relapsed and refractory gastric cancer is still not satisfactory. For the moment, the combination of 5-Fu and cisplatin is regularly used. Capecitabine and Oxaliplatin are new generation drugs of 5-Fu and cisplatin. The current study is to evaluate the efficacy and toxicity of this combination.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 70 years
- •Patients with histologically confirmed, unresectable, recurrent and/or metastatic gastric adenocarcinoma
- •ECOG performance status ≤1
- •Measurable diseases according to the RECIST
- •Relapse or refractory after the first-line chemotherapy
- •Sign ICF,normal laboratory findings:absolute neutrophil count and platelet count ≥ 2.0×109/L and 80×109/L, respectively, hepatic function (total serum bilirubin ≤ UNL, transaminases ≤ 1.5 times upper normal limit) and renal function (calculated creatinine clearance ≥ 60 ml/min).
排除标准
- •Relapse within 6 months after adjuvant chemotherapy which contained oxaliplatin
- •Have used any of drugs in the regimen in first-line chemotherapy
- •Pregnant or lactating women,serious uncontrolled diseases and intercurrent infection
- •The evidence of CNS metastasis
- •History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
- •Received other chemotherapy regimen after metastasis
- •Participated in other clinical trials.
研究组 & 干预措施
Combine Chemotherapy
Experimental
XELOX(Xeloda and oxaliplatin combination)
干预措施: Capecitabine and Oxaliplatin (Drug)
结局指标
主要结局
Response Rate
时间窗: 2-6 months
次要结局
- time to progression and overall survival(1 year)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Phase II Study of Neoadjuvant XELOX + Lapatinib in HER2(+) Gastric Cancer Patients With Liver MetastasisHER2-positive Gastric Cancer Patients With Liver MetastasisNCT02015169Samsung Medical Center32
Unknown
2 期
The Maintenance Therapy of Capecitabine of Advanced Gastric CancerAdvanced Gastric CancerNCT02038621The Second People's Hospital of Sichuan224
Unknown
2 期
Combination of Capecitabine and Oxaliplatin in Metastatic Nasopharyngeal CarcinomaNasopharyngeal NeoplasmsNCT00363831The University of Hong Kong42
Unknown
2 期
XELOX With Capecitabine Maintenance or XELOX in Elderly Metastatic Adenocarcinoma of StomachGastric CancerNCT01798251Harbin Medical University40
Unknown
2 期
Efficacy and Safety of Oxaliplatin Combined With Capecitabine as Neoadjuvant Chemotherapy for Locally Advanced Colon Cancer PatientsColorectal CancerNCT02415829Fudan University55