malignant tumors
Conditions
Sponsors
Shanghai TCM-integrated Hospital, Shanghai University of TCM
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intestinal flora;PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| DAO;D-LA;ET;Cytokines;T cell subset;OS;frequency, grading and time of occurrence of irAEs;KPS score;ECOG score;TCM syndrome;Hormone use; | — |
Countries
China
Contacts
Public ContactYi Zhong
Shanghai TCM-integrated Hospital, Shanghai University of TCM
Outcome results
None listed