immune related adverse events caused by immune checkpoint inhibitors
Conditions
Interventions
intervention group:ICIs plus platinum-based chemotherapy+Gegen Qinlian tablet
control group:ICIs plus platinum-based chemotherapy
Sponsors
China-Japan Friendship Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Patients with stage IIIB to IV NSCLC (AJCC Lung Cancer Staging System, 2017 edition 8); 2) No any previously standard antitumor therapy; 3) Age 18 to 80 years; 4) ECOG PS 0-1; 5) Predictive survival period > 3 months. 6) No contraindications to immunotherapy after baseline assessment; 7) Submitted informed consent.
Exclusion criteria
Exclusion criteria: 1) Those who suffered from other cancers such as colorectal cancer within the last 3 years, except for cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors; 2) Patients with uncontrolled brain metastases; 3) Patients with previous digestive surgery within 3 years and untreated irritable bowel syndrome, ulcerative colitis, or crohns disease; 4) Patients with autoimmune diseases history or who require glucocorticoids or immunosuppressants; 5) Patients with infectious diseases that required antibiotic treatment or who have used antibiotics within the last month; 6) Patients with anaphylaxis, contraindication, or intolerance to Ge-Gen-Qin-Lian tablet, or have factors affecting oral drugs (such as dysphagia, ileus); 7) Patients suffering from serious cardiovascular and cerebrovascular diseases, hematopoietic system diseases, or diseases of the liver, kidneys, and other vital organs; 8) Participated in other drugs or treatment clinical trials within 4 weeks prior to randomization; 9) Those who have the psychotropic drug abuse history and are unable to quit; 10) Patients who are unable to cooperate in evaluation due to mental or psychological disorders; 11) Patients with comorbidities that seriously endanger their safety or affect their ability to complete the study, or who are considered unsuitable for inclusion for other reasons, according to the researchers judgment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of immune related adverse events;Incidence of severe immune related adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Severity of immune related adverse events;Objective response rate;Severity of severe immune related adverse events;Progression-free survival;1-year PFS rate; | — |
Countries
China
Contacts
Public ContactHuijuan Cui
Outcome results
None listed