Toripalimab in Combination With Axitinib in Patients With Localized Mucosal Melanoma

Exclusion Criteria

• •1. Previously treated with anti-PD-1, anti-PD-L1, anti-PD-L2, or antiangiogenic drugs;
• •2. Known allergy to Toripalimab or Axitinib or excipient of the study drug;
• •3. Patients with ocular melanoma or melanoma with unknown primary foci;
• •4. Pregnant and breastfeeding women;
• •5. Abnormal coagulation function \[activated partial thromboplastin time (APTT)\> 43 s, or international normalized ratio (INR) \> 1.5×ULN\], or hemorrhagic tendency or hemorrhagic event occurred within two months prior to enrollment (e.g., gastrointestinal hemorrhage, hemorrhagic gastric ulcer, etc.), or receiving thrombolytic or anticoagulation therapy;
• •6. Currently having serious and uncontrolled acute infection, or suppurative infection, chronic infection, or prolonged wound healing;
• •7. Having serious heart disease, including congestive heart failure, uncontrollable high-risk arrhythmia, unstable angina pectoris, myocardial infarction, severe valvular heart disease and refractory hypertension;
• •8. Having neurological, mental disease or psychiatric disorder that can not be easily controlled, poor compliance, inability to cooperate and narrate therapeutic response;
• •9. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
• •10. Concomitantly other Malignancies;
• •11. Concomitant participation in other clinical trials;
• •12. Positive HIV antibody, or positive HCV antibody/HCV-RNA, or positive HBsAg or HBcAb whilst HBV DNA copy \>2000 IU/ml;
• •13. Active autoimmune diseases requiring systemic treatment in the past two years (e.g., use of disease-regulating drug, corticosteroid or immunosuppressant), relevant replacement therapy is allowed (e.g., thyroxine, insulin or physiological corticosteroid replacement therapy for renal or pituitary insufficiency);
• •14. Vaccination of live vaccine within 4 weeks prior to the start of study;
• •15. Other severe, acute or chronic medical diseases or abnormalities in laboratory examination possibly increasing the relevant risk in study participation or possibly interfering the interpretation of study results as judged by the investigators.