Toripalimab in Combination With Axitinib in Patients With Localized Mucosal Melanoma

Inclusion Criteria:

1. Being voluntary to sign the informed consent form, with good compliance andwillingness to cooperate with follow-up;
2. Age of 18-75 years, male or female;
3. Histopathologically diagnosed mucosal melanoma;
4. ECOG PS score 0 or 1;
5. Being considered to be able to be completely resected after multidisciplinary (including surgeon, oncologist and radiologist) discussion, and systemic stagingexamination improved prior to enrollment (need to include cranial enhanced CT/MRI,bone scan, thoracic, abdominal and pelvic enhanced CT/MRI (enhanced MRI of head andneck, gynecological examination additionally needed for female genital melanoma,colonoscopy additionally needed for rectal melanoma), B mode ultrasonography ofsuperficial lymph node, or systemic PET-CT) demonstrated no regional or distantmetastasis;
6. No contraindications for the treatment, including normal peripheral hemogram,basically normal hepatic and renal function as well as ECG:

• Peripheral hemogram: white blood cell (WBC) ≥3.5×109/L, neutrophil (ANC) ≥1.5×109/L, platelet (PLT) ≥100×109/L, hemoglobin (Hgb) ≥90 g/L;
• Liver function: alanine aminotransferase (ALT) ≤1.5×ULN, aspartateaminotransferase (AST) ≤1.5×ULN, and total bilirubin (TBil) ≤1.5×ULN;
• Renal function: blood urea nitrogen ≤ ULN, creatinine ≤ ULN;

7. Use of highly-effective contraceptive methods during the whole study for men ofreproduction ability or women of pregnant possibility (e.g. oral contraceptives,intrauterine contraceptive device, abstinence of sexual intercourse or barriercontraception in combination with spermatocide), and continuation of contraception for 12 months after the end of study treatment.

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, orinternational normalized ratio (INR) > 1.5×ULN], or hemorrhagic tendency orhemorrhagic event occurred within two months prior to enrollment (e.g.,gastrointestinal hemorrhage, hemorrhagic gastric ulcer, etc.), or receivingthrombolytic 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, uncontrollablehigh-risk arrhythmia, unstable angina pectoris, myocardial infarction, severe valvularheart disease and refractory hypertension;
8. Having neurological, mental disease or psychiatric disorder that can not be easilycontrolled, poor compliance, inability to cooperate and narrate therapeutic response;
9. History of allogeneic organ transplantation or allogeneic hematopoietic stem celltransplantation;
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 HBcAbwhilst 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), relevantreplacement therapy is allowed (e.g., thyroxine, insulin or physiologicalcorticosteroid 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 laboratoryexamination possibly increasing the relevant risk in study participation or possiblyinterfering the interpretation of study results as judged by the investigators.