A randomized, controlled, double-blind trial for the efficacy of Xianglianwan in the immunotherapy of advanced malignant tumors

Shanghai TCM-integrated Hospital, Shanghai University of TCM0 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. in line with the diagnostic criteria for malignant tumors, pathological examination to confirm the diagnosis, TNM stage IV;
•2. receiving PD-1/L1 monoclonal antibody, CTLA-4 antibody, or immunological combination therapy;
•3. aged 18-80 years old, male or female;
•4. KPS score >=60 points, estimated survival >=3 months.

•1. combined with severe primary diseases such as cardiovascular and cerebrovascular diseases, as well as mental illness;
•2. In the course of clinical research, the compliance is poor and the data is incomplete;
•3. the diagnosis is not clear;
•4. subjects who have not performed the provisions of this protocol;
•5. Observing subjects who are incomplete and unable to evaluate the test results and side effects;
•6. participated in other clinical trials in the past 3 months;
•7. have received other immune-related treatments or Chinese medicine treatments that may affect immune function;
•8. During the course of medication, patients who are suffering from other diseases due to non-pharmaceutical factors cannot continue to complete immunotherapy;
•9. ECOG 3~4;
•10. used antibiotics, systemic corticosteroids (or less than 10 mg/day of prednisone) and other immunosuppressants within 1 month prior to enrollment;
•11. with inflammatory bowel disease, radiation enteritis, rheumatism and other diseases;
•12. Other serious comorbidities.

发起方

Shanghai TCM-integrated Hospital, Shanghai University of TCM