ITMCTR1900002830尚未招募1 期
A clinical study of Traditional Chinese Medicine prolonging the survival of advanced gastric cancer patients by regulating the immunosuppressive cell population
Jiangsu Province Hospital of Chinese Medicine0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 18 至 75(—)
- 性别
- All
入选标准
- •1. Patients with pathological diagnosis of gastric cancer;
- •2. Patients with histologically or cytologically confirmed stage III after resection or IV,who cannot undergo radical surgery or postoperative recurrence and metastasis;
- •3. KPS scores >60;
- •4. Aged from 18 to 75 years old;
- •5. Patients with life expectancy of at least 6 months;
- •6. Patients who provide written informed conset to participate in the study according to the GCP criteria;
- •7. Childbearing age women whose urine pregnancy test is negative within 7 days before enrollment. All the patients and their spouse should abstinence all the time or at fixed periods during this trail or take at least 2 effective contraceptives. Abstinence or contraceptives still need to be used for 2 years after the trail.
排除标准
- •1. Patients who is unable to swallow oral medications(including with digestive tract obstruction and jejunostomy;
- •2. Patients with symptomatic brain metastasis or mental disorder;
- •3. Patients who has severe cardiovascular disease, hepatopathy, kidney disease or blood disease;
- •4. Patients whose laboratory examination before enrollment is abnormal: Blood routine examination: ANC< 2.0x10^9/L, Hb< 90g/L, PLT <80x10^9/L, Renal function: Cr>1.5 UNL, CCr<50ml/min, liver function:TBil>1.5 UNL, ALT(SGPT) and AST(SGOT) >1.5×UNL;
- •5. Patients who are pregnant, nursing;
- •6. Patients who are substance abuse,or with clinical ,mental and social features which is interference for the study and informed consent.
研究者
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