Tumor cardiovascular
Conditions
Interventions
Control group:Glucose injection
Experimental group:Niacinamide injection
Sponsors
The First Hospital of Lanzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Subjects must be fully informed and provide written consent prior to undergoing screening procedures; 2. Age range from 18 to 80 years, regardless of gender; 3. Pathological confirmation of malignant tumor is required; 4. No previous treatment with immune checkpoint inhibitors for at least 1 year; 5. According to RECIST version 1.1, there must be at least one measurable lesion visible on CT or MRI scans. 6. The patient's ECOG performance status was between 0 and 1; 7. The patient must have adequate organ function, defined as: a) Blood system: ANC >=1.0×10^9/L, platelets >=70×10^9/L, hemoglobin >=80 g/L; b) Cardiac function: LVEF >=50%; c) Liver function: total bilirubin =50mL/min; e) Coagulation function: PT, APTT or INR if receiving anticoagulant therapy <=1·5 times ULN. 8.The expected survival time should exceed 3 months.
Exclusion criteria
Exclusion criteria: 1. Individuals with severe allergies to the primary components and excipients of immune checkpoint inhibitors, contrast agents, or with an allergic constitution; 2. Has not recovered to <= grade 1 or baseline levels from the adverse effects of previous antitumor therapy (excluding alopecia and <= grade 2 neuropathy); 3. Currently participating in or receiving investigational therapy, or has received another investigational therapy within 3 months prior to initiating the investigational therapy; 4. Untreated severe arrhythmia; 5. Uncontrolled pericardial effusion; 6. History of acute myocardial infarction within the past month; 7. Pregnant or lactating female patients; 8. Subjects deemed unsuitable for other reasons by the investigator; 9.Incomplete data, non-compliance with treatment, failure to adhere to follow-up schedule, loss of follow-up, or withdrawal from study by researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cardiac function change(LVEF); | — |
Secondary
| Measure | Time frame |
|---|---|
| Myocardial Enzyme(such as cTnI/hs-cTnI,BNP/NT-proBNP,CK/CKMB,MYOcMyBP-C);Echocardiography(such as LVEF,LVEDV,LVESV,GLS);Stress/rest myocardial perfusion imaging(such as EF,EDV,ESV,PER,PFR);Death(Acute myocardial infarction,Malignant arrhythmia,Acute heart failure,Re-hospitalization for heart failure);Electrocardiogram (presystole, conduction block, QRS wave width, PR interval, QT interval); | — |
Countries
China
Contacts
Public ContactBai Ming
The First Hospital of Lanzhou University
Outcome results
None listed