Efficacy and safety of Yifei Sanjie Recipe combined with anlotinib in the treatment of the second line or above IIIB-IVB non-small cell lung cancer patients: a pilot study

The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine0 个研究点开始时间: 待定最近更新: 2023年2月20日

试验速览

暂无简介。

•1. Pathologically and/or cytologically diagnose with IIIB-IVB non-small cell lung cancer;
•2. Patients with negative driver genes who have received at least one type of systemic chemotherapy (including combined immune checkpoint inhibitors or anti-vascular drug therapy) have progressed, relapsed, or become intolerable; Patients with positive driver gene (EGFR mutation or ALK fusion positive) who have progressed, relapsed, or become intolerable after receiving corresponding standard targeted drug therapy;
•3. Aged from 18 to 75 years, male or female;
•4. Eastern Cooperative Oncology Group (ECOG) performance scale (PS) score of 0-2;
•5. The expected survival time>=24 weeks;
•6. A measurable lesion based on the RECIST criteria;
•7. Adequate liver and kidney function (creatinine clearance rate>=60ml/min; total bilirubin<=1.5xULN; alanine aminotransferase, aspartate aminotransferase<=2.5xULN));
•8. Hemoglobin>100g/L, platelet count>100x10^9/L, neutrophils>1.5x10^9/L;
•9. Agree to contraception during the trial and within six months after the trial ends;
•10. Patients or their family members signed the informed consent.

•1. With unstable brain metastases or at risk of bleeding after being evaluated by researchers;
•2. Previously used anlotinib or apatinib;
•3. Concomitant with other types of malignant tumors;
•4. Difficulties with oral medications (such as dysphagia, chronic diarrhea, and intestinal obstruction);
•5. Female patients with positive pregnancy test results 7 days before enrollment;
•6. Women who are pregnant or breastfeeding;
•7. Patients with mental illness or mental retardation;
•8. Allergy or intolerance to the study drug.

发起方

The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine