ITMCTR2000003240尚未招募1 期
Randomized and placebo-controlled clinical Study of Bushen Tiaoyuan Tongluo Formula in Combination with PD-1 Inhibitor and Chemotherapy for Advanced Non-small Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
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 100（—）
- 性别
- All
入选标准
- •1)Patients with stage IIIB / stage IV NSCLC diagnosed by pathology or cytology. 2) The selected patients are the first diagnosis and will be the first-line chemotherapy patients. 3) Subjects voluntarily joined the study, signed an informed consent form, had good compliance, and cooperated with follow-up. 4) Patients with CNS metastasis can be fully treated, and the neurological symptoms of the subjects can return to baseline levels at least 2 weeks before enrollment (except for residual signs or symptoms related to CNS treatment); 5) Patients do not use corticosteroids or receive prednisone (or equivalent) <= 10 mg / day at a stable or gradually decreasing dose; 6) Patients must have measurable lesions that are examined by CT or MRI. Tumor imaging evaluation was performed within 28 days before randomization; 7) Age 18 and over, regardless of gender; 8) ECOG score: 0-1; 9) Expected survival time >= 12 weeks; 10) The function of important organs meets the following requirements (excluding any use within 14 days before the first medication. Blood components and cell growth factors): Absolute neutrophil count >= 1.5 x 10^9 / L; Platelet >= 100 x 10^9 / L; Hemoglobin >= 9g / dL; Serum albumin >= 3g / dL; Thyrotropin (TSH) <= ULN (if abnormal, FT3 and FT4 levels should be investigated at the same time, if FT3 and FT4 levels are normal, they can be included in the group); Bilirubin <= ULN; ALT and AST <= 1.5 times ULN; AKP <= 2.5 times ULN; Serum creatinine <= 1.5 times ULN or creatinine clearance >= 60mL / min. 11) Female patients with non-surgical sterilization or childbearing age need to use a medically approved contraceptive method (such as an IUD, contraceptive or condom) during the study treatment and within 3 months after the end of the study treatment period; Surgical sterilized female patients of childbearing age must have anegative serum or urine HCG test within 72 hours before study enrollment; and must be non-lactating; for males, surgical sterilization, or agree to be given during the trial and after the last administration Use appropriate methods for contraception within 3 months;
排除标准
- •1) With cancerous meningitis;
- •2) Patients with active central nervous system (CNS) metastasis;
- •3) The subject has any active autoimmune disease or has a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, body inflammation, vasculitis , Nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or asthma that has been completely relieved in childhood, can be included without any intervention after adulthood; subjects with asthma requiring medical intervention with bronchodilators cannot be included);
- •4) Subjects are being treated with immunosuppressive agents or systemic or absorbable local hormones to achieve immunosuppression (dose > 10mg / day prednisone or other therapeutic hormones), and within 2 weeks before enrollment Still in use;
- •5) Previously used anti-tumor vaccine or other anti-tumor drugs with immunostimulating effect;
- •6) Previously treated with anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, anti-CD137 antibody or anti-CTLA-4 antibody (including ipilimumab or specific action on T cell co-stimulation or checkpoint pathway Any other antibody or drug);
- •7) Subjects have congenital or acquired immune deficiency (such as HIV infection), or active hepatitis (B
- •Liver reference: HBV DNA detection value exceeds the upper limit of normal value; Hepatitis C reference: HCV virus titer or RNA detection value exceeds the upper limit of normal value);
- •8) Patients with active tuberculosis (TB) infection.
- •9) Past and present history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug
- •Patients with objective evidence related to pneumonia and severely impaired lung function;
- •10) EGFR mutation (regardless of mutation type) or ALK translocation.
- •11) Other patients with serious primary diseases such as heart, brain, kidney and hematopoietic system, mental illness; pregnant and lactating women; critically ill and poor compliance.
研究者
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