Efficacy and Safety of Sorafenib in New-Onset Type 1 Diabetes Mellitus

Inclusion Criteria: 1. Subjects with written informed consent; 2. Age: 18-60 years; 3. Diagnosis of T1DM according to ADA criteria within 1 year prior to starting study drug; 4. Islet autoantibody positivity (one or more of GADA, IA-2A, ZnT8A); 5. Stimulated C-peptide \> 200 pmol/L; 6. Participants of childbearing age who are sexually active must agree to use of effective birth control until the end of the study Exclusion Criteria: 1. Non-Type 1 Diabetes Mellitus. 2. Signs of chronic active infection (e.g., hepatitis, tuberculosis, cytomegalovirus, Epstein-Barr virus, herpes zoster, or toxoplasmosis), or screening laboratory evidence consistent with chronic active infection: * Positivity for human immunodeficiency virus * Positive purified protein derivative or interferon-γ release assay suggestive of tuberculosis * Positivity for hepatitis B surface antigen And acute infections (e.g., respiratory, urinary tract, or gastrointestinal infections) must be resolved before reevaluation; 3. Severe hypertension (systolic blood pressure \> 200 mmHg and/or diastolic blood pressure \> 110 mmHg, or those requiring the concurrent use of 3 or more antihypertensive medications); 4. Previous or current cerebro-cardiovascular diseases: * Congestive heart failure (NYHA Class III-IV) * Myocardial infarction * unstable ischemic heart disease, * Arrhythmia * Syncope of cardiac or unknown origin * Structural defects * Signs of QT prolongation on electrocardiogram (450 ms in men, 470 ms in women) * Stroke * Transient Ischemic Attack 5. Hematological conditions: * Anemia (hemoglobin below 120 g/L in men and 110 g/L in women) * Leukopenia (\<4000 leukocytes per μL) * Thrombocytopenia (\<100,000 platelets per μL) * Neutropenia (\<1500 neutrophils per μL) 6. Abnormal coagulation function during the screening period: Prothrombin time (PT) is prolonged beyond the upper limit of normal for 3 seconds and/or activated partial thromboplastin time (APTT) is prolonged beyond the upper limit of normal for 10 seconds; 7. Liver and renal dysfunction: * acute or chronic active hepatitis * alanine aminotransferase or aspartate aminotransferase \>2·0 times the upper limit of normal persisting for persisting for more than one week * impaired renal function defined by estimated glomerular filtration rate (according to the CKD-EPI) of \< 60 mL/min/1.73 m2 8. History of severe gastrointestinal diseases such as gastrointestinal ulcers, gastrointestinal hemorrhage, pyloric stenosis, gastric bypass surgery, acute or chronic pancreatitis, etc; 9. Have had any major surgery within 8 weeks prior to screening or will require major surgery during the study; 10. Anticipated ongoing use of diabetes medications other than insulin; 11. Known hypersensitivity to sorafenib, or history of severe allergic reactions to other medications (e.g., anaphylaxis, angio-edema, or serious cutaneous drug reactions); 12. Use of medications in the last month known to cause an ongoing change in the course of type 1 diabetes or immunological status (e.g., high-dose inhaled, extensive topical, or systemic glucocorticoids); 13. Previous treatment with sorefenib or related multikinase inhibitor; 14. Concurrent use of medications that affect cytochrome P450 3A4 or use of drugs that interact with sorefenib, leading to altered plasma concentrations of the drugs; 15. For men: unwilling to adopt contraception during the whole study period; 16. For women: * Pregnancy or breastfeeding * Less than 100 days postpartum before enrollment * Unwilling to defer pregnancy during the 1-year study period 17. Known coagulation disorders or use of anticoagulants (e.g., warfarin, rivaroxaban, or low molecular weight heparin); 18. Other situations in which the investigator considers it inappropriate to participate in this trial.