immune checkpoint inhibitors pneumonia
Conditions
Interventions
Control group:G1 patients: Pingfei oral liquid placebo
G2-3 patients: Methylprednisolone sodium succinate / methylprednisolone tablets (2 mg/kg/d), tapered according to CIP symptoms and imaging findings, combined with Pingfei oral liquid placebo
Experimental group:G1 patients: Pingfei oral liquid
G2-3 patients: Methylprednisolone sodium succinate / methylprednisolone tablets (2 mg/kg/d), tapered according to CIP symptoms and imaging findings, combined with Pingfei oral liquid
Sponsors
China-Japan Friendship Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Malignant tumors diagnosed by cytology or histopathology meeting the diagnostic criteria of immune checkpoint inhibitors pneumonia after ICI; 2) Patients with grade 1~3 (Management of Immune Checkpoint Inhibitor-related Toxicity by CSCO2021); 3)Those who meet the diagnostic criteria of traditional Chinese medicine syndrome of deficiency of both qi and yin and accumulation of phlegm and heat; 4) KPS > 60; Predictive survival period > 6 months; 5) Aged 18 - 80 years; 6) The subject did not participate in other drug clinical studies within 1 month;Submitted informed consent.
Exclusion criteria
Exclusion criteria: Those with one of the following conditions may not be included in the trial 1) Patients with clear evidence of pulmonary infection or tumor progression; 2) Patients with severe immune adverse reactions in other organs; 3) Patients who had received glucocorticoid therapy for more than one week 4) Patients with obvious impairment of heart lung liver and kidney accompanied by severe complications such as coronary heart disease cerebral infarction COPD etc. 5) Do not cooperate with the treatment 6)Pregnant and lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glucocorticoid dosage and time;Disease duration; | — |
Secondary
| Measure | Time frame |
|---|---|
| quality of life assessment;TCM Syndrome Information Collection Form;DLCO; | — |
Countries
China
Contacts
Public ContactJiabin Zheng
China-Japan Friendship Hospital
Outcome results
None listed