Oncocardiology
Conditions
Interventions
Control Group:Accept monotherapy or combination anti-tumor regimens with ICIs.
Experimental Group:Anti-tumor regimen plus Qishen Yiqi dripping pills.
Sponsors
Tianjin Medical University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients with malignant tumors receiving monotherapy or combination therapy with ICIs for the first time; 2. Patients who meet the diagnostic criteria for moderate to high-risk populations for ICIs-related cardiovascular toxicity; 3. Patients who meet the diagnostic criteria for qi deficiency and blood stasis syndrome; 4. Patients aged 18 years or older, with no gender restrictions; 5. Patients with good baseline cardiac function: clinical assessment of New York Heart Association (NYHA) cardiac functional classification as Class I; and baseline echocardiography, electrocardiogram, and myocardial biomarker test results showing no clinically significant acute myocardial injury or severe cardiac dysfunction; 6. Patients with a Karnofsky Performance Status (KS) score > 60; 7. Patients who provide written informed consent.
Exclusion criteria
Exclusion criteria: 1 Patients who had regularly taken traditional Chinese medicine or Chinese patent medicine for the treatment of cardiovascular diseases within 14 days before the trial, or were participating in clinical trials of other drugs or medical devices that may affect the efficacy or safety evaluation of this study ; 2 Patients with severe cardiovascular disease in the past, such as uncontrolled heart failure, active myocarditis, uncontrolled clinically significant arrhythmia, acute coronary syndrome or cardiovascular events requiring hospitalization in the past 6 months, may affect the endpoint of the study or the safety of the subjects. 3 patients with severe and uncontrolled medical diseases, including severe infection, uncontrolled hypertension or diabetes, obvious liver and kidney dysfunction, and respiratory failure, which may affect the implementation of the study, safety evaluation or endpoint determination ; 4 pregnant and lactating women ; 5 patients with mental illness, cognitive dysfunction or other conditions, resulting in the inability to cooperate with research and treatment, visits or examinations ; 6 those who were known to be allergic to the study drug or its components, or had contraindications for the use of the study drug ;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence rate of cardiac injury events caused by ICIs-based drugs.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of ECG abnormalities;Echocardiography parameter changes;Cardiac Troponin I (cTnI);Creatine kinase isoenzyme (CK-MB);B-type natriuretic peptide (BNP) or N-terminal pro-B-type natriuretic peptide (NT-proBNP);White Blood Cell Count (WBC);C-reactive protein (CRP);Erythrocyte Sedimentation Rate (ESR);lymphocyte (LYM);Neutrophil (NEU);Monocyte (MONO);Adjustment rate of anti-tumor treatment plan;The incidence rate of new addition or adjustment of cardiovascular drugs;Cardiovascular portion CTCAE grading changes;NYHA Heart Function Classification Changes;Karnofsky Performance Status Scale (KPS);Quality of Life Questionnaire for Cancer Patients (EORTC QLQ-C30);Liver Function;renal function; | — |
Countries
China
Contacts
Public ContactLi Yan Yang
Tianjin Medical University Cancer Hospital
Outcome results
None listed