ITMCTR2100004629招募中4 期
Real world research for Pingxiao capsule to treat triple negative breast cancer research
适应症
试验速览
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
- Female
入选标准
- •1. Triple negative breast cancer confirmed by histology or cytology;
- •2. The patients agreed to be treated;
- •3. They were 18-75 years old;
- •4. The expected survival time was more than 12 weeks;
- •5. ECoG status score was 0-2;
- •6. According to RECIST 1.1, there was at least one measurable lesion;
- •7. The organ function level must meet the following requirements:
- •Hematological indexes: absolute neutrophil count >= 1.5 x 10^9 / L, platelet count >= 80 x 10^9 / L, hemoglobin >= 9.0 g / dl (can be maintained by blood transfusion);
- •Liver function: total bilirubin <= 1.5 times the upper limit of normal value, alanine aminotransferase and aspartate aminotransferase <= 2.5 times the upper limit of normal value, if there is intrahepatic transaminase <= 5 times the upper limit of normal value;
- •Renal function: creatinine <= 1.25 times the upper limit of normal value, and creatinine clearance rate >= 60ml / min;
- •8. Women of childbearing age must have urine pregnancy test within 7 days before treatment, and the result is negative, and they are not in lactation
- •During the lactation period, the male should agree to use appropriate contraceptive methods or have undergone surgical sterilization during the trial period and within 8 weeks after the last administration of the trial drug;
- •9. Ability to comply with research and follow-up procedures;
- •10. Patients have the ability to understand and sign informed consent voluntarily.
排除标准
- •Subjects who meet any of the following exclusion criteria are not eligible to participate in the study:
- •1. Patients who have had any systemic anti-cancer treatment, including cytotoxic drug therapy, targeted drug therapy, experimental treatment, adjuvant chemotherapy or neoadjuvant chemotherapy (but patients with recurrence after stopping for more than 6 months can be selected);
- •2. The target focus was treated by radiotherapy or radio frequency;
- •3. Combination of phenytoin, carbamazepine, rifampin, barbital or St. John's grass;
- •4. Other malignant tumors have been developed in the past 5 years, except for the cured basal cell carcinoma, cervical in situ cancer, surgical treatment of localized prostate cancer or surgical resection of breast duct carcinoma in situ;
- •5. The patient has one or more of the following conditions:
- •Patients with symptomatic central nervous system metastasis or spinal cord compression;
- •A large number of pleural effusion or pericardial effusion;
- •Any unstable systemic disease (including active infection, poor control of hypertension, unstable angina, congestive heart failure, liver, kidney or metabolic diseases);
- •It is impossible to accept oral administration, need high energy nutrition in vein, and have performed operations and activities that have previously affected absorption;
- •Patients with peptic ulcer and chronic diarrhea;
- •It is known that it is allergic to relevant components of Pingxiao capsule;
- •6. The researchers believe that subjects may not be able to complete the study or may not comply with the requirements of the study (for management reasons or other reasons).
研究者
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