ITMCTR2100004241招募中1 期
A randomized and placebo-controlled phase II clinical study of Yiqijiedu compound combined with anti-PD-1 antibody in the treatment of non-small cell lung cancer patients with chemotherapy resistance
ongHua Hospital, Shanghai University of Traditional Chinese Medicine0 个研究点开始时间: 待定最近更新:
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
- Interventional study
入排标准
- 年龄范围
- 18 至 —（—）
- 性别
- All
入选标准
- •1. Over 18 years old, male or female
- •2. Locally advanced or metastatic NSCLC patients with stage IIIA - IV diagnosed by histology or cytology;
- •3. According to RECIST v1.1, subjects had at least one measurable lesion;
- •4. Disease progression or intolerance after first-line platinum based chemotherapy;
- •5. Progression after EGFR TKIs treatment in patients with driver gene mutation (including 1/2 generation EGFR-TKI treatment progression, T790M - patients; T790M + patients, receiving 3 generation EGFR-TKI treatment progression);
- •6. The expected survival time is more than 6 months;
- •7. ECOG PS score: 0-2;
- •8. The organ function level meets the following requirements (accept the examination results within 14 days before randomization):
- •Hematological indexes: absolute neutrophil count>=1.5*10^9/L, platelet count>=70*10^9/L, hemoglobin >= 90 g/L;
- •Liver function: total bilirubin <= 1.5 ULN, alanine aminotransferase and aspartate aminotransferase <= 3 ULN, if there is intrahepatic transaminase <= 5.0 ULN;
- •Renal function: creatinine <= 2.5 ULN;
- •Color Doppler echocardiography: LVEF >= 50%.
- •9. Sign informed consent, good compliance and cooperate with follow-up.
排除标准
- •1. Small cell lung cancer confirmed by histology or cytology, mixed squamous cell carcinoma and lung cancer with neuroendocrine components;
- •2. Have received any T cell costimulation or immune checkpoint therapy in the past, including but not limited to CTLA-4 inhibitors, PD-1 inhibitors, PD-L1 / 2 inhibitors or other drugs targeting T cells;
- •3. Interstitial lung disease, drug-induced pneumonia, radiation pneumonia or active pneumonia with clinical symptoms or severe pulmonary dysfunction;
- •4. Any active autoimmune disease or history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, etc.);
- •5. Patients with definite or suspected brain metastasis. Patients with a history of brain metastasis must have completed treatment and no longer need corticosteroid treatment;
- •6. Subjects who received other forms of anti-tumor therapy (including other herbal drugs, chemotherapy, targeted therapy and radiotherapy) in the study;
- •7. Participated in any other drug clinical study within 4 weeks before the first administration;
- •8. Subjects without measurable lesions;
- •9. Poor general condition (large amount of hydrothorax and ascites, severe infection and high fever that need repeated drainage without control), obvious cachexia, severe dysfunction of important organs, severe anemia and nutritional metabolic disorder can not be improved in a short time;
- •10. There are various bleeding tendency or coagulation dysfunction, or history of thrombosis or bleeding;
- •11. Pregnant or lactating women;
- •12. Subjects with mental illness, alcoholism, inability to quit smoking, drug use or drug abuse;
- •13. Patients considered unsuitable for this study.
研究者
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