NCT01756183Unknown2 期
Exploratory Study on the S-1 + Paclitaxel Chemotherapy for Creating the Operation Chance in the Patients With Unresectable Gastric Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- radical resection rate
研究概览
简要总结
Exploratory the S-1 + Paclitaxel Chemotherapy for Creating the Operation Chance in the Patients with Unresectable Gastric Cancer
详细描述
To assess the effectiveness and safety of S-1 + Paclitaxel for the peri-operative chemotherapy in Chinese patients with unresectable gastric cancer, so as to further find out the optimal protocol for the peri-operative chemotherapy in the patients with gastric 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
- •Unresectable gastric cancer as proven histologically (AJCC, Version 7) under any following condition: Unable radical excision due to the local metastasis or invasion Metastasis to the lymph node beside the abdominal aorta Non-extensive metastasis to liver (not more than three metastatic foci of radical excision)
- •Definitely diagnosed as above stage of stomach cancer before the operation via CT or MRI, ultrasonic endoscopy and blood tumor antigen test, or through the laparoscopy if necessary
- •Untreated (e.g. radiotherapy, chemotherapy, target therapy and immunotherapy)
- •ECOG (Eastern Cooperative Oncology Group) : 0~2
- •Age: 18~75 years old
- •Normal hemodynamic indices before the recruitment (including blood cell count and liver/kidney function). For example: WBC>4.0×109/L, NEU >1.5×109/L, PLT>100×109/L, BIL<1.5 times of upper limit of normal reference value, ALT and AST<2.5 times of upper limit of normal reference value, and CRE<1.2mg/dl
- •Good cardiac function before the recruitment, no seizure of myocardial infarction in past half year, and controllable hypertension and other coronary heart diseases
- •Not concomitant with other uncontrollable benign diseases before the recruitment (e.g. the infection in the lung, kidney and liver)
- •Not participating in other study projects before and during the treatment
- •Signed the Informed Consent Form
排除标准
- •Not conforming to above inclusion criteria
- •Distal metastasis to lung, brain and bone (except the liver)
- •Ever operation on the stomach
- •Operation intolerance due to other systemic basic diseases
- •Ever administered other drugs (including TCM drugs) before the recruitment, or no guarantee of progress according to the study requirement after the recruitment
- •Allergy to the drugs in this protocol
- •Pregnant or lactating women
- •Women at childbearing age and of pregnancy desire during the study
研究组 & 干预措施
S-1 + Paclitaxel Chemotherapy
Experimental
S-1: 60mg twice daily (after the breakfast and supper) for two weeks, and then suspend for one week.
Paclitaxel: 150 mg/m2, iv, 3h, at D1
干预措施: S-1 + Paclitaxel Chemotherapy (Drug)
结局指标
主要结局
radical resection rate
时间窗: 3 months
radical resection rate
次要结局
- Adverse Events(6 months)
- reaction rate(2 months)
- overall survival time(3 years)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
2 期
Exploratory Study on the Paclitaxel + S-1 + Oxaliplatin (PSOX) for Locally Advanced or Advanced Gastric CancerGastric CancerNCT03263741Affiliated Hospital of Qinghai University20
暂停
不适用
Phase I/II Trial of S-1 plus paclitaxel combination chemotherapy in elderly patients with non-small lung canceron-small cell lung cancerJPRN-UMIN000003782Kyoto prefectural University of Medicine45
已完成
2 期
A Phase II Study of Paclitaxel+S-1 for previously treated Non-Small Cell Lung CancerAdvanced or relapsed Non-Small Cell Lung CancerJPRN-UMIN000003719Osaka Medical Center for Cancer and Cardiovascular Diseases50
Enrolling By Invitation
2 期
Safety and Efficacy of Systemic Chemotherapy Plus PD-1 Inhibitor in Combination With Bevacizumab in Gastric Cancer With Peritoneal MetastasisGastric Cancer Peritoneal MetastasesNCT06487715Wuhan Union Hospital, China42
已完成
1 期
A Phase I/II Study of Paclitaxel, Carboplatin and YM155 (Survivin Suppressor) in Subjects With Solid Tumors (Phase I) and Advanced Non-Small Cell Lung Carcinoma (Phase II)Solid TumorsNSCLCNCT01100931National Cancer Institute (NCI)42