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临床试验/ITMCTR1900002830
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

发起方
Jiangsu Province Hospital of Chinese Medicine

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