ITMCTR2000003833尚未招募1 期
Clinical study of Jianpi Jiedu recipe combined with SOX chemotherapy in the first-line treatment of advanced gastric cancer
Shuguang hospital affiliated to Shanghai university of traditional 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. Meet the diagnosis of gastric cancer stage IV, and the diagnostic criteria are based on the National Health and Wellness Committee's Guidelines for the Diagnosis and Treatment of Gastric Cancer (2018 Edition); Clinical staging standard is based on tnm staging of gastric cancer in ajcc/uicc of union for international cancer control (8th edition);
- •2. TCM syndrome differentiation is spleen deficiency and toxic accumulation; The criteria of syndrome differentiation refer to Guiding Principles for Clinical Research of New Drugs of Traditional Chinese Medicine (2002 Edition) and Guidelines for Diagnosis and Treatment of Tumors with Traditional Chinese Medicine (Chinese Medicine Association standard ZYXH/T136 ~ 156-2008):
- •(l) Main symptoms: bloating, sallow complexion, emaciation, poor taste of rice bran, pale tongue and greasy fur;
- •(2) Secondary symptoms: listlessness, fatigue, dry or loose stool, and thin or astringent pulse;
- •3. Aged 18~75 years old, male or female; Estimated survival time >=12 weeks; The ECOG physical state score is 0~2;
- •4. there is at least one measurable lesion;
- •5. Patients with gastric cancer undergoing first-line treatment in stage iv; In accordance with the indications of chemotherapy, S-1 plus oxaliplatin regimen was used for chemotherapy; At least 3 weeks from the end of the last chemotherapy or radiotherapy;
- •6. Human epidermal growth factor receptor 2(Her2) was negative by immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH);
- •7. Patients voluntarily participate and sign informed consent.
排除标准
- •1. in the past month, there are serious infections, injuries and major operations;
- •2. Patients with severe primary diseases such as hepatic and renal insufficiency (ast, alt > 2 ULN, serum creatinine >ULN), pulmonary insufficiency, heart failure and acute myocardial infarction;
- •3. Pregnant, pregnant or lactating women;
- •4. those who are allergic to the traditional Chinese medicine components of this medicine;
- •5. Mental patients;
- •6. Patients who participated in other clinical trials in recent 3 months;
- •7. Other conditions that the researcher thinks are not suitable to participate in this clinical trial.
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