Endostar Plus Toripalimab as Adjuvant Therapy for Resectable Stage III-Oligometastatic Stage IV Cutaneous Melanoma

Exclusion Criteria

• •1. Patients with a history of allergic reactions to biological products;
• •2. Patients with previous or concurrent malignancies within 5 years (except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
• •3. Any active autoimmune disease or history of autoimmune disease (such as, but not limited to, Autoimmune hepatitis, interstitial pneumonia, enteritis, Vasculitis, nephritis; asthma in which the subject needs medical intervention with Bronchiectasis cannot be included); However, the following patients are allowed to be included: Vitiligo, psoriasis, alopecia without systemic treatment, well controlled type I diabetes, hypothyroidism with normal thyroid function after replacement treatment;
• •4. Patients who need to use immunosuppressants, or systemic or absorbable local hormone therapy to achieve immunosuppression (dose\>10mg/day prednisone or other equivalent therapeutic hormone), and continue to use within 2 weeks after the first administration;
• •5. Patients with any signs or history of bleeding, regardless of severity; Patients with any bleeding or bleeding event ≥CTCAE Grade 3 within 4 weeks prior to the first dose; Or digestive tract diseases such as unhealed wound, fracture, active gastric and duodenal ulcer, ulcerative colitis or active bleeding of unresected tumor, or other conditions that may cause gastrointestinal bleeding and perforation as judged by the investigator;
• •6. Patients with any severe and/or uncontrolled disease, including:
• •1. Patients with poorly controlled blood pressure (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥90mmHg);
• •2. Unstable angina pectoris, myocardial infarction, ≥ Grade 2 congestive heart failure, or arrhythmia requiring treatment (including QTc≥480ms) within 6 months after the first administration;
• •3. Active or uncontrolled serious infection (≥CTCAE 2);
• •4. Known history of clinically significant liver disease, including viral hepatitis, and known hepatitis B virus (HBV) carriers must exclude active HBV infection, i.e., HBV DNA positive (\>1×103 copies/mL or\>500 IU/mL); Known hepatitis C virus (HCV) infection and HCV RNA positive (\>1×1000 copies/mL or\>100 IU/mL), or other decompensated liver disease, chronic hepatitis requiring antiviral therapy;
• •5. HIV test positive;
• •6. Diabetes mellitus poorly controlled (fasting blood glucose ≥CTCAE 2);
• •7. Urine routine examination indicates urine protein ≥++, and 24-hour urine protein quantification is confirmed to be\>1.0 g;
• •7. According to the judgment of the investigator, the patient has other factors that may lead to the forced termination of the study, such as other serious diseases (including mental diseases) requiring concomitant treatment, serious laboratory abnormalities, family or social factors that may affect the safety of the subject, or the collection of data and samples.