Toripalimab Combined With Anlotinib in Unresectable Locally Advanced or Metastatic Acral Malignant Melanoma

Inclusion criteria

• .18 and 75 years; Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; Life expectancy ≥ 3 months.
• .Histologically or cytologically confirmed unresectable locally advanced or metastatic acral malignant melanoma.
• .At least one measurable lesion, as defined by RECIST v1.1, that has not been irradiated. New lesions that have developed in a previously irradiated field may be used as sites of measurable disease assuming all other criteria are met.
• .The main organs function are normally. Adequate bone marrow, hepatic, and renal function documented within 4 weeks prior to treatment as documented by:absolute neutrophil count ≥ 1.5\*10\^9/L; platelets ≥ 100 x 10\^9/ L; hemoglobin ≥ 90 g/L(no blood transfusion within 14 days before enrollment) serum creatinine ≤1.5×ULN，total bilirubin ≤ 1.5 x upper limit of normal (ULN); aspartic transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN , unless there are liver metastases in which case AST and ALT ≤5.0 x ULN;INR, aPTT, PT≤1.5 x ULN; left ventricular ejection fraction (LVEF) ≥50%. serum creatinine ≤1╳ULN，creatinine clearance \>50 umol/L；urinary protein \<2+ by urine dipstick. If dipstick is ≥2+ then a 24-hour urine collection can be done and the patient may enter only if urinary protein is \<2 g per 24 hours；Women of childbearing potential must have a negative serum or urine pregnancy test are received within 7 days before the randomization. Women of non childbearing age are defined as having been postmenopausal for at least 1 year, or having undergone sterilization or hysterectomy.Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 1 year after the last dose of study with an annual failure rate of less than 1% (such as intrauterine devices , contraceptives or condoms) .
• .Written and voluntary informed consent. 8.No evidence of preexisting uncontrolled hypertension as documented by 2 baseline blood pressure readings taken at least 1 hour apart. The baseline systolic blood pressure readings must be ≤140, and the baseline diastolic blood pressure readings must be ≤90. Patients whose hypertension is controlled by antihypertensive therapies are eligible