Immunotherapy-associated cardiac injury
Conditions
Interventions
Mild ICIAM-placebo group:Placebo
Subclinical ICIAM-Shengmaiyin granule group:Shengmaiyin granule
Mild ICIAM-Songjiaodihuang decoction granule group:Songjiaodihuang decoction granule
Subclinical ICIAM-placebo group:Placebo
Sponsors
China-Japan Friendship Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Diagnosis of malignancy confirmed by cytology or histopathology; 2) Development of ICIAM after treatment with ICIs meeting the diagnostic criteria of subclinical/mild disease; 3) TCM diagnosis meets the diagnostic criteria of qi and yin deficiency/heat-scorched yin syndrome; 4) KPS score > 60 expected survival > 6 months 18 years = age = 80 years.
Exclusion criteria
Exclusion criteria: 1) Clear evidence suggesting cardiac injury not caused by ICIs; (ii) Combination of severe adverse immune reactions in other organs; 3) Has received glucocorticoid therapy for more than 1 week; 4) clinically significant cardiac/pulmonary/hepatic/renal impairment or with serious comorbidities such as coronary artery disease cerebral infarction COPD.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effective rate of treatment;cTn recovery time; | — |
Secondary
| Measure | Time frame |
|---|---|
| Common symptoms of tumor and quality of life score;Cardiac function and related indexes;Progression rate of immune checkpoint inhibitor-associated myocarditis;Effective rate of Traditional Chinese Medicine syndromes; | — |
Countries
China
Contacts
Public ContactJiabin Zheng
China-Japan Friendship Hospital
Outcome results
None listed