immunotherapy-related Adverse Reactions
Conditions
Interventions
TCM group (deficiency of both qi and yin):Sheng-Mai-Yin decoction
TCM group (downward flow of damp-heat):Simiao pill
control group:None
Sponsors
China-japan Friendship Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: ? Patients with malignant tumors confirmed by pathology ? The antitumor regimen containing PD1/PD-L1 immunotherapy was applied for the first time ?According to the clinical differentiation of two chief TCM physicians, the syndrome was deficiency of both qi and yin or downward flow of damp-heat; If inconsistent, the third chief TCM physician will make a ruling based on syndrome differentiation ? No other immune system related diseases ?Age: 18~80 years old ?ECOG score: 0~2 ? Estimated survival =6 months ?No major organ dysfunction, heart, liver, kidney function is basically normal, the following laboratory values: neutrophils > 1.5 × 10^9 /L; platelets > 100 × 10^9 /L; hemoglobin > 90 g/L; bilirubin within normal limits or < 1.5 × the upper limit of normal (ULN); aspartate aminotransferase (AST)/alanine aminotransferase (ALT) < 2.5 × ULN; serum creatinine < 1.5 × ULN; endogenous creatinine clearance (CCR) = 60 mL/min (calculated using the Cockcroft-Gault formula); ?Understand the situation of this study, cooperate with the evaluation of relevant indicators, and have signed the informed consent
Exclusion criteria
Exclusion criteria: ?Diagnosis of other immune system related diseases ?Currently taking other traditional Chinese medicine and proprietary Chinese medicine ?TCM syndrome differentiation for other syndrome types (non-Qi-Yin deficiency type or damp-heat wagging type) ?There are serious, uncontrolled organic diseases or infections, such as decompensated heart, lung, kidney failure, etc ? Pregnant or lactating women ? Participants in other clinical trials currently or within 4 weeks ?A significant neurological and psychiatric history, including dementia that may affect comprehension and informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of immunotherapy-related adverse reactions;Grade of immunotherapy-related adverse reactions; | — |
Secondary
| Measure | Time frame |
|---|---|
| the rate of modification of immunotherapy schedule;Evaluation of antitumor efficacy; | — |
Countries
China
Contacts
Public ContactChao Deng
China-Japan Friendship Hospital
Outcome results
None listed