ITMCTR2200005508招募中1 期
Clinical study of the traditional Chinese medicine wenyangtongluo formula combined with toripalimab plus apatinib and tegio as the third line for advanced gastric cancer
Department of Oncology of Integrated Traditional Chinese and Western Medicine, High-tech Campus, First Affiliated Hospital of Anhui0 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
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational study
入排标准
- 性别
- All
入选标准
- •(1) According to the 8th edition of the TNM staging of gastric cancer by the International Association for Gastric Cancer Research and the Joint Committee on Cancer Classification of the United States, patients with histopathological or cytological diagnosis of advanced gastric cancer stage IV;
- •(2) Between 18 and 75 years old;
- •(3) Third-line treatment patients who have received two chemotherapy regimens after treatment failure, according to the RECIST 1.1 standard proved that the first and second-line treatment failed or were intolerable;
- •(4) The KPS score is greater than 60 points; the expected survival period is more than 3 months;
- •(5) No obvious signs of blood system disease, no bleeding tendency; no serious liver and kidney damage;
- •(6) Complete the imaging examination within 2 weeks before the selected trial as the basic data;
- •(7) The patient is informed, has good compliance, and has signed an informed consent.
排除标准
- •(1) Does not meet the inclusion criteria;
- •(2) Pregnant or lactating women;
- •(3) TCM syndrome differentiation is for patients with non-Yang deficiency and toxin stagnation syndrome;
- •(4) Patients with severe liver, kidney and hematopoietic system dysfunction, and mental illness;
- •(5) Accompanied by other malignant or uncontrollable diseases, defined as follows:
- •· Suffered from myocardial infarction, unstable angina or congestive heart failure 6 months before entering the study;
- •· There is an unstable arrhythmia that requires clinical treatment;
- •· There are infections that are difficult to control;
- •·Chronic obstructive pulmonary disease worsens or there are other respiratory diseases that require hospitalization;
- •· Diabetes is poorly controlled (fasting blood glucose (FBG)> 10mmol/L);
- •·Urine routines suggest that urine protein is =++, and the 24-hour urine protein quantitative is confirmed to be greater than 1.0 g;
- •· Active tuberculosis, etc.;
- •(6) Patients who are receiving other clinical research drug treatments or other clinical trials;
- •(7) Those who are known to be allergic to teriprizumab, apatinib, and ticgio drugs;
- •(8) Other situations in which the investigator believes that the patient should not participate in this trial.
研究者
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