Malignant Tumor
Conditions
Interventions
irAE group:ICIs treatment
Control group (non-irAE group):ICIs treatment
Sponsors
Fudan University Zhongshan Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Tumor patients who received immunotherapy voluntarily participated in this research, with good compliance, able to cooperate with the test requirements to complete observation and follow-up, and signed the informed consent; 2. (1) Population with irAE after ICIs treatment: The selected patients have been diagnosed with malignant tumors (including melanoma, kidney cancer, lung cancer, cervical cancer, breast cancer, gastric cancer, liver cancer, intrahepatic cholangiocarcinoma, bone cancer, blood tumor, skin cancer, etc.), and treated with ICIs (including PDL1 antibody alone, PD1 antibody alone, CTLA4 antibody alone or in combination with Ipilimumab and Nivolumab), irAEs (including pneumonia, myocarditis, encephalitis, enteritis, diabetes, Vitiligo, rash, erythema, Sjogren's syndrome, systemic lupus erythematosus, colitis, Crohn's disease, diarrhea, hepatitis, hypophysitis, thyroid dysfunction, acute adrenal insufficiency or adrenal crisis, pancreatitis, hematologic toxicity, neurological Toxicity, scleritis, conjunctivitis, uveitis, orbititis, polyarthritis or arthralgia, kidney disease, pancreatic disease, lupus erythematosus or rheumatoid myalgia, etc.); (2) People without irAE after ICIs treatment: The selected patients have been diagnosed with malignant tumors (including melanoma, kidney cancer, lung cancer, cervical cancer, breast cancer, gastric cancer, liver cancer, intrahepatic bile duct cancer, bone cancer, hematological tumor, skin cancer, etc.), and undergo ICIs (including individual cancers) No irAEs (including pneumonitis, myocarditis, encephalitis, enteritis, diabetes, vitiligo, Rash, erythema, Sjogren's syndrome, systemic lupus erythematosus, colitis, Crohn's disease, diarrhea, hepatitis, hypophysitis, thyroid dysfunction, acute adrenal insufficiency or adrenal crisis, pancreatitis, hematologic toxicity, neurotoxicity, scleritis, conjunctivitis, uveitis, orbititis, polyarthritis or arthralgia, kidney disease, pancreatic disease, lupus erythematosus or rheumatoid myalgia, etc.), and no irAEs occurred within one year of follow-up.
Exclusion criteria
Exclusion criteria: 1. For irAE patients: Cancer patients had autoimmune disease prior to ICIs treatment. 2. For non-irAE patients: (1) The treatment time of tumor patients without irAEs after ICIs treatment is less than 6 weeks; (2) Tumor patients have autoimmune diseases before ICIs treatment; (3) Tumor patients who did not have irAEs after ICIs treatment were followed up for one year after discharge. If irAEs occurred, they were excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor size;Blood biochemistry;Blood immunology;Imaging tests; | — |
Countries
China
Contacts
Public ContactDuojiao Wu
Fudan University Zhongshan Hospital
Outcome results
None listed