Exploratory Study on the Efficiency and Safety of Paclitaxel + S-1 + Oxaliplatin Chemotherapy in the Patients With Locally Advanced or Advanced Gastric Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Objective response rate(ORR)
研究概览
简要总结
Explore the Efficiency and Safety of Paclitaxel + S-1 + Oxaliplatin (PSOX) Chemotherapy in the Patients with Locally Advanced or Advanced Gastric Cancer
详细描述
To assess the Efficiency and safety of Paclitaxel + S-1 + Oxaliplatin(PSOX) in the Patients with Locally Advanced or Advanced 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histopathology or cytopathology proven gastric cancer or gastroesophageal adenocarcinoma;
- •Locally advanced, or recurrent, or metastasis disease；
- •Chemotherapy-naive or disease progress at least 6 months after adjuvant chemotherapy completed;
- •Life expectancy of at least 3 months;
- •ECOG score 0-1;
- •Age: 18~70 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;
- •Voluntarily signed the informed consent.
排除标准
- •Previously treated with first-line chemotherapy;
- •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
Paclitaxel + S-1 + Oxaliplatin group
Paclitaxel: 135 mg/m2, iv, 3h, at D1 ; S-1: 40mg twice daily for patients with a body surface area (BSA) < 1.25 m2, 50mg twice daily for patients with a BSA of 1.25 m2 to < 1.5 m2, 60mg twice daily for patients with a BSA of ≥ 1.5 m2 for two weeks, and then suspend for one week; Oxaliplatin: 85 mg/m2, iv, 2h, at D1.
干预措施: Paclitaxel + S-1 + Oxaliplatin (Drug)
结局指标
主要结局
Objective response rate(ORR)
时间窗: 2 years
The sum of complete remission (CR) rate and partial remission (PR) rate.
次要结局
- Disease control rate(DCR)(2 years)
- Progression-free survival(PFS)(2 years)
- Overall survival(OS)(2 years)
研究者
Jiuda Zhao
Professor
Affiliated Hospital of Qinghai University