NCT01797913已完成2 期
The Study of Gemcitabine in the Maintenance Treatment of Advanced Non-small Cell Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
assess the efficacy and safety of gemcitabine in the maintenance treatment of advanced non-small cell lung cancer
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18~75 years Patients who were diagnosed by the histologic, cytologic diagnosis of IIIb-IV non-small cell lung cancer patients who have acceptted combination chemotherapy based on platinum 4 course,SD OR PR,the CR patients should accept 6 course of combination chemotherapy.
- •3~8 weeks after patients complete first line chemotherapy(include radiotherapy) Ecog0-2 Expected life time longer than 3 monthes
- •Normal laboratory values:
- •leucocyte ≥ 4×109/L
- •neutrophil ≥ 1.5×109/L
- •platelet ≥ 100×109/L
- •Hemoglobin ≥ 10g/L
- •AST ≤ 2.5×ULN (≤ 5×ULN if liver metastasis) Signed written informed consent
排除标准
- •Patients have used drugs according to protocol
- •Uncontrolled infection of Bacterial or virus or fungal
- •Patients with other malignant tumor
- •Uncontrolled brain metastases
- •Female patients during their pregnant and lactation period, or patients without contracep
研究组 & 干预措施
gemcitabine
Experimental
干预措施: gemcitabine (Drug)
结局指标
主要结局
PFS
时间窗: from the first cycle of treatment (day one) to two month after the last cycle
次要结局
未报告次要终点
研究者
Chang Jian Hua
Vice director of department of chemotherapy
Fudan University
研究点 (1)
Loading locations...
相似试验
Unknown
2 期
Study of Gemcitabine Maintenance Treatment in Patients With Extensive SCLC PatientsSmall Cell Lung CancerNCT02039518Fudan University160
招募中
不适用
The maintenance therapy by Gemcitabine after the Gemcitabine(GEM)+Cisplatin (CDDP) combined therapy over a postoperative recurrence / advanced biliary tract cancer:a phase II, multicenter studyJPRN-UMIN000012983Kawasaki Medical School25
Unknown
不适用
Gemcitabine as a Single Agent in the Maintenance Chemotherapy of Patients With Metastatic Breast CancerStage IIIB, IV, Recurrent, and Metastatic Breast CancerGemcitabineMaintenance ChemotherapyNCT02188693Xijing Hospital267
已完成
2 期
2nd Line Gemcitabine Monotherapy for Transitional Cell Carcinoma of Urothelium (TCC) After CDDP RegimenUrologic NeoplasmsCarcinoma, Transitional CellNCT00191971Eli Lilly and Company40
进行中（未招募）
3 期
Maintenance Therapy With Toripalimab Combined With Capecitabine/Placebo for Recurrent and Metastatic Nasopharyngeal CarcinomaMaintenance TherapyNasopharyngeal CarcinomaNCT05869227XIANG YANQUN166